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On Sep 2018

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"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."

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Sanjay Gandhi institute of trauma and orthopedics,
On Aug 2018

Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".

Dr. Mamta Gupta
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018

Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.

Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
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Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."

Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
On May 11,2011

Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."

Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
On April 2011

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.

Dr. Anuradha
On Jan 2020

Important Notice

Original article / research
Year : 2023 | Month : November | Volume : 17 | Issue : 11 | Page : SC06 - SC09 Full Version

Safety and Efficacy of Lactobacillus rhamnosus GG (ATCC 53103) in Children with Functional Abdominal Pain: A Randomised, Double-blinded, Placebo-controlled Trial

Published: November 1, 2023 | DOI:
Taral Javerilal Kesharani, Sanjay Mandot, Arvind Kumar Yadav, Anjali Vyas, Shubham Jain

1. Resident, Department of Paediatrics, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India. 2. Professor, Department of Paediatrics, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India. 3. Professor, Department of Pharmacology, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India. 4. Resident, Department of Paediatrics, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India. 5. Resident, Department of Paediatrics, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India.

Correspondence Address :
Dr. Taral Javerilal Kesharani,
Old PG Hostel, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India.


Introduction: Functional Abdominal Pain (FAP) is a major concern in developing countries, especially in school-going children. Recently, some probiotics have shown clinical evidence in managing abdominal diseases. The role of Lactobacillus rhamnosus GG (LGG) (ATCC 53103) for FAP in children has not been studied in India.

Aim: To evaluate the safety and efficacy of LGG (ATCC 53103) in children with FAP in terms of frequency, severity, and adverse effects.

Materials and Methods: This double-blinded, placebo-controlled study was conducted at Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India, from February 2021 to July 2022, after obtaining permission from the Institutional Ethical Committee (IEC). Children aged 5-18 years with FAP were included in the study. A total of 82 children were included in the study and were randomised into the LGG group and placebo group. The LGG group received LGG (ATCC 53103), and the placebo group received sugar powder for a period of four weeks. These patients were followed-up after 2, 4, and 8 weeks for evaluation. Student’s t-test (unpaired) was used for quantitative data, and Chi-square test was used for qualitative data. Statistical Package for the Social Sciences (SPSS) PC-20.0 version was used to evaluate the data.

Results: Out of 82 children, a total of 77 children were enrolled during the study period, with 38 in the LGG group and 39 in the placebo group. The severity of abdominal pain at four weeks and eight weeks was significantly less compared to placebo (p-value=0.009 and p-value=0.01, respectively). The frequency of abdominal pain at four weeks and eight weeks was also significantly less compared to placebo (p-value ≤0.001 and p-value≤0.001, respectively). There was no statistically significant difference in adverse effects between the two groups (p-value =0.115).

Conclusion: This study concluded that LGG decreases both the severity and frequency of abdominal pain in children aged 5-18 years without any significant side-effects. Thus, it can be safely used in the management of childhood FAP.


Bowel syndrome, Probiotics, Wong-Baker pain FACES scale

FAP, not otherwise specified, occurs atleast four times per month with either intermittent or continuous abdominal pain not associated with a particular activity or coincident to another physiological event, such as menses or eating. It cannot be explained by any other underlying medical condition and lasts for atleast two months (1). FAP is described as continuous, nearly continuous, or frequent recurrent pain localised in the abdomen but poorly related to gut function (2). Because of this change in bowel function, this type of abdominal pain is often referred to as ‘FAP’.

Estimates of the incidence and prevalence vary depending on the diagnostic criteria and setting, but about 10-20% of the school-aged population may be affected. However, it is rarely observed in children below five years and adults above 18 years. The prevalence rate of FAP ranges from 0.3-19% in school-going children in the United States and Europe (3).

In recent years, both research and consumers interest in probiotics have grown. Increasing clinical evidence supports some of the proposed health benefits related to the use of probiotics, particularly in managing certain abdominal diseases. Probiotics, which are regulated as dietary supplements and foods, consist of yeast or bacteria. Although the exact mechanisms by which probiotics may exert their actions in patients with FAP are not fully understood, several mechanisms have been suggested (4). The available pharmacological interventions are limited in children, and therefore, management has focused on combined approaches, including mind-targeted interventions and diet (probiotics) (5). In the past few years, probiotics have shown some effectiveness in the treatment of FAP. Multiple studies in adults (6),(7),(8) have shown that certain probiotic strains are clinically more effective than placebo in treating some categories of FAP, mainly irritable bowel syndrome. However, limited paediatric data are available (9).

Very few studies are available in the literature on LGG (ATCC 53103) for FAP, and no study was found in India among children [9,10]. The present study was undertaken to evaluate the efficacy of LGG (ATCC 53103) in children with FAP in terms of frequency and severity, as the primary objective, and to evaluate safety in terms of adverse effects, as the secondary objective.

Material and Methods

This double-blinded randomised controlled trial was conducted at the Department of Paediatrics, Geetanjali Medical College and Hospital in Udaipur, Rajasthan, India from February 2021 to July 2022, after obtaining approval from the Institutional Research Review Board and IEC (Ref: GU/HREC/EC/2021/1894). This study was also registered with the Clinical Trial Registry of India (CTRI registration No: 2022/01/039373). Consecutive sampling was used to enroll the patients, and informed patient consent/assent was obtained from all the parents.

Inclusion criteria: Children aged between 5 to 18 years of either gender, who met the FAP criteria according to Rome IV (11), were included in the study.

Exclusion criteria: Children with any chronic disease, those who had used probiotics in the last two months, or had a history of previous abdominal surgery were excluded from this study.

Sample size: The following formula was used to calculate the sample size:

N=(Zα+Z1-β)2P(1-P)/E2 (12)

where N is the sample size, Zα is 1.96 at a 95% confidence level, Z1-β is 0.8413 at 80% power of the study, ‘P’ is the expected prevalence, and ‘E’ is the margin of absolute error. The prevalence was estimated to be 2.7% (13), and the margin of error was set at 7.5%. The final sample size calculated was 37. Considering a 10% dropout rate in each group, a minimum of 41 children were enrolled in each group during the study period.

After the initial assessment for eligibility in 91 children, 9 children were excluded due to refusal to participate, previous use of probiotics, and previous abdominal surgery. Therefore, a total of 82 children were enrolled in the study during the study period. Three children from the LGG group and two children from the placebo group were lost to follow-up. Hence, the results of 77 children were studied (Table/Fig 1).


Children who were clinically diagnosed according to the Rome IV criteria were enrolled in the study. After obtaining a detailed medical history, conducting a clinical examination, and relevant investigations, the patients were randomly assigned to either the LGG or placebo groups. Randomisation was performed using computer-generated random numbers. The LGG group received one sachet of LGG (ATCC 53103), which contained 10 billion (1010) Colony Forming Units (CFU), while the placebo group received one sachet of sugar powder. Both sachets weighed 1 gram and had the same shape, taste, dimensions, and appearance. Both preparations were administered orally, one sachet per day, for four weeks. Neither the participants nor the researchers knew which sachet was given to each participant until the study was complete. The sachets were administered by a third person who was not involved in the research. The children returned for follow-up visits after 2, 4, and 8 weeks to monitor the progress of the study.

The primary outcome assessed was the severity and frequency of abdominal pain, and the secondary outcome was the occurrence of adverse effects in both groups. The Wong-Baker Pain Scale, which consists of six types of pain faces with corresponding scores, was used to measure the severity of abdominal pain in children (14). Additionally, demographic parameters such as age, gender, residence, and socio-economic status were compared in both groups. The Modified Kuppuswamy socio-economic scale was used to classify the children based on socio-economic data (15).

Statistical Analysis

The collected data were transformed into variables, coded, and entered into Microsoft Excel. The data were then analysed and statistically evaluated using SPSS-PC-20.0 version. Quantitative data were expressed as mean and standard deviation, and the difference between the two comparable groups was assessed using Student’s t-test (unpaired). On the other hand, qualitative data were expressed as percentages. Statistical differences between proportions were tested using the Chi-square test or Fisher’s exact test. A p-value <0.05 was considered statistically significant.


No statistically significant difference was found in the demographic data between both the groups (Table/Fig 2).

The pain severity, as rated on the Wong-Baker Faces Pain Scale (14), is shown in (Table/Fig 3),(Table/Fig 4). There was no statistically significant difference at baseline (p-value=0.149) and two weeks (p-value=0.152) between both groups. However, there was a statistically significant difference at four weeks (p-value=0.009) and eight weeks (p-value=0.01) between both groups (Table/Fig 3),(Table/Fig 4).

The pain frequency, measured in terms of episodes per week, in the LGG group was 3.63±1.42 at baseline, 3.44±1.37 at two weeks, 1.63±1.06 at four weeks, and 0.86±0.83 at eight weeks. In the placebo group, these values were 3.17±1.41, 3.05±1.39, 2.79±1.09, and 2.33±0.91, respectively. There was no statistically significant difference at baseline (p-value=0.171) and two weeks (p-value=0.219) between both groups. However, there was a statistically significant difference at four weeks (p-value≤0.001) and eight weeks (p-value≤0.001) between both groups (Table/Fig 5).

In the LGG group, a total of two children (5.3%) experienced vomiting at two weeks, and three children (7.9%) experienced vomiting at four weeks. No side-effects were reported in the placebo group. There was no statistically significant difference in adverse effects between both groups (p-value=0.115).


The FAP can be episodic or continuous. Although the exact cause is not known, nerve signals or chemicals secreted by the gut or brain may make the gut more sensitive to triggers that normally do not cause significant pain. Probiotics are commonly targeted for illnesses associated with the gastrointestinal tract, mainly due to their ability to restore gut flora. Due to their safety profile, probiotics seem to be an attractive therapeutic option for gastrointestinal tract diseases. These are used for the prevention and treatment of various medical conditions and to support general wellness (10),(16),(17).

In this present study, probiotics were compared with a placebo to assess their safety and efficacy. The authors attempted to reduce possible confounding factors by using a sugar powder as a placebo. In the present study, both groups were demographically similar. The severity of abdominal pain, based on the Wong-Baker Faces scale (14), significantly reduced in the LGG group after eight weeks of intervention. There was no significant change in the severity of abdominal pain in the placebo group. A significant change occurred at the 4th (p-value=0.009) and 8th week (p-value=0.001) when these two groups were compared.

Similar results were found in a study conducted by Francavilla R et al., in which 141 children treated with LGG showed a significant reduction in the severity of abdominal pain (p-value<0.01) (10). Gawron´ska A et al., also found that the LGG group was more likely to have treatment success (no pain) compared to those in the placebo group (25% versus 9.6%) (9). Additionally, Kianifar H et al., observed in their study that LGG administration resulted in a significant difference in abdominal pain severity after four weeks (p-value=0.001) (18).

These positive results may be due to the fact that LGG, upon reaching the intestine, inhibits the growth or reduces the activity of pathogens by colonising the gut. It involves the production of various substances, such as hydrogen peroxide, organic acids, bacteriocins, and biosurfactants that are toxic to pathogenic microorganisms. LGG also has the ability to produce a low-molecular-weight compound that inhibits broad-spectrum bacteria (19),(20),(21).

In contrast to previous studies by Bausserman M and Michail S, who observed that LGG had no significant effect on abdominal pain severity compared to placebo in FAP (22), this discrepancy may be attributed to the use of inulin as a placebo, which acted as a prebiotic (22). Prebiotics are substances that help in the growth of protective bacteria in the gut (23).

In the study conducted by Francavilla R et al., where 141 children were treated with LGG, the number of pain episodes per week at baseline was 3.7 in the probiotic group and 3.5 in the placebo group. After 12 weeks, it decreased to 1.1 and 2.2, respectively (p-value<0.01), and at the end of the follow-up period, episodes of pain decreased to 0.9 (0.5) in the probiotic group and 1.5 (1.0) in the placebo group (p-value<0.02) (10). Similarly, Gawron´ska A et al., (p-value=0.02) and Weizman Z et al., (p-value<0.02) found in their studies that LGG reduced the frequency of pain compared to children who were given a placebo (9),(24). The decrease in the frequency of pain in the LGG group could also be explained based on the probiotic mechanism (19),(20),(21).

Only the LGG group reported vomiting as a side-effect in the present study, but it was statistically non significant. Kajander K et al., found gastrointestinal symptoms as an adverse effect in the participants taking probiotics in their study (25). Other studies have also reported similar results, but they were non significant (9),(10).


The present study was a single-centre study. Other multicentre studies conducted in different parts of India can be performed on a larger population. The study may be underpowered for specific diagnoses. In one group, a placebo was used, and the effect of the placebo may be responsible for the lack of an obvious effect of the LGG treatment. The study was conducted in a tertiary care hospital, so there is a possibility that more severely affected children were included. There were also chances of recall bias during follow-ups.


LGG can be safely used in the management of children with FAP as it decreases both the severity and frequency of abdominal pain in children aged 5-18 years without any significant side-effects.


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DOI and Others

DOI: 10.7860/JCDR/2023/64956.18659

Date of Submission: Apr 25, 2023
Date of Peer Review: Jun 30, 2023
Date of Acceptance: Aug 10, 2023
Date of Publishing: Nov 01, 2023

Author declaration:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

• Plagiarism X-checker: May 01, 2023
• Manual Googling: Jul 07, 2023
• iThenticate Software: Aug 08, 2023 (12%)

Etymology: Author Origin

Emendations: 6

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