Guide to designing, conducting, publishing, and communicating results of clinical studies involving probiotic applications in human participants

Shane, Andi L.; Cabana, Michael D.; Vidry, Stéphane; Merenstein, Dan; Hummelen, Ruben; Ellis, Collin L.; Heimbach, James T.; Hempel, Susanne; Lynch, Susan V.; Sanders, Mary Ellen; Tancredi, Daniel J.

doi:10.4161/gmic.1.4.12707

Cited by 63 publications

(48 citation statements)

References 63 publications

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“…These guidelines were developed for drug trials, but several papers have provided guidance on designing clinical trials for specific functional food ingredients [16,17,18]. Consensus guidelines have recently been collated for designing, conducting and reporting human intervention studies to evaluate the health benefits of foods [19].…”

Section: Discussion On Objective 1: To Provide Guidance On the Level mentioning

confidence: 99%

Documentation of Functional and Clinical Effects of Infant Nutrition: Setting the Scene for COMMENT

et al. 2012

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The Early Nutrition Academy and the Child Health Foundation, in collaboration with the Committee on Nutrition, European Society for Paediatric Gastroenterology, Hepatology and Nutrition, held a workshop in March 2011 to explore guidance on acquiring evidence on the effects of nutritional interventions in infants and young children. The four objectives were to (1) provide guidance on the quality and quantity of evidence needed to justify conclusions on functional and clinical effects of nutrition in infants and young children aged <3 years; (2) agree on a range of outcome measures relevant to nutrition trials in this age group for which agreed criteria are needed; (3) agree on an updated ‘core data set’ that should generally be recorded in nutrition trials in infants and young children, and (4) provide guidance on the use of surrogate markers in paediatric nutrition research. The participants discussed these objectives and agreed to set up six first working groups under the auspices of the Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT). Five groups will aim to identify and define criteria for assessing key outcomes, i.e. growth, acute diarrhoea, atopic dermatitis and cows’ milk protein allergy, infections and ‘gut comfort’. The sixth group will review and update the ‘core data set’. The COMMENT Steering Committee will discuss and decide upon a method for reaching consensus which will be used by all working groups and plan to meet again within 2 years and to report and publish their conclusions.

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Section: Discussion On Objective 1: To Provide Guidance On the Level mentioning

confidence: 99%

Documentation of Functional and Clinical Effects of Infant Nutrition: Setting the Scene for COMMENT

et al. 2012

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“…Guidelines for probiotic in a review for study design, target populations, selection of placebo and probiotic microorganism, duration of follow-up, outcome, and end point measurements, safety assessment and regulatory considerations are proposed by Shane, A. L. et al, (2010). [13]. Most common adverse event reported was flatulence in both the groups.…”

Section: Discussionmentioning

confidence: 92%

Comparative Study of Efficacy and Safety of Azithromycin Alone and in Combination With Probiotic in the Treatment of Impetigo in Children

Sudha

Nirmala

Ramanathan

et al. 2017

Int J Curr Pharm Sci

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Objective: Impetigo is a superficial infection of the skin that involves only the epidermis. It affects mostly children, usually on exposed areas of the body (eg. The face and the legs). Staphylococcus aureus is the most important causative organism. Streptococcus pyogenes (i.e.) group A betahemolytic streptococcus) causes fewer cases, either alone or in combination with S. aureus. The objective of this study is to find out the efficacy and safety of azithromycin alone and in combination with probiotic among children suffering from impetigo.Methods: This prospective, randomized, single-blinded interventional study was conducted for a period of 6 mo in pediatric OPD and dermatology OPD in Rajah Muthiah Medical College and Hospital. A total of 100 patients, randomly divided into two groups with 50 patients in each group. Group, I patients treated with Azithromycin 10 mg/kg/d for 5 d. Group II patients treated with Azithromycin 10 mg/kg/d for 5 d with probiotic (50 million spores of Lactobacillus sporegens, Streptococcus faecalis 30 million spores, clostridium butyricum 2 million spores, Bacillus mesentericus 1 million spores) twice daily for 5ds.Results: Reduction in a number of lesions and wound area, clinical response were highly significant in Azithromycin with the probiotic-treated group. Conclusion:In this study, probiotic bacteria may counteract the inflammatory process beyond the intestinal milieu. The results of this study indicate that Azithromycin with probiotic is effective in the treatment of impetigo.

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“…We will record all of these variables in an attempt to perform the most comprehensive study possible. Furthermore, we have taken into account recently published recommendations for future clinical trials using probiotics by the International Scientific Association for Probiotics and Prebiotics [30]. …”

Section: Discussionmentioning

confidence: 99%

An oral preparation of Lactobacillus acidophilus for the treatment of uncomplicated acute watery diarrhoea in Vietnamese children: study protocol for a multicentre, randomised, placebo-controlled trial

Kolader

Vinh

Tuyet

et al. 2013

Trials

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BackgroundDiarrhoeal disease is a major global health problem, particularly affecting children under the age of 5 years. Besides oral rehydration solution, probiotics are also commonly prescribed to children with acute watery diarrhoea in some settings. Results from randomised clinical trials (RCTs) in which investigators studied the effect of probiotics on diarrhoeal symptoms have largely shown a positive effect; yet, the overall quality of the data is limited. In Vietnam, probiotics are the most frequently prescribed treatment for children hospitalised with acute watery diarrhoea, but there is little justification for this treatment in this location. We have designed a RCT to test the hypothesis that an oral preparation of Lactobacillus acidophilus is superior to placebo in the treatment of acute watery diarrhoea in Vietnamese children.MethodsThis RCT was designed to study the effect of treatment with L. acidophilus (4 × 109 colony-forming units/day) for 5 days for acute watery diarrhoea against a placebo in 300 children ages 9 to 60 months admitted to hospitals in Vietnam. Clinical and laboratory data plus samples will be collected on admission, daily during hospitalisation, at discharge, and at follow-up visits for a subset of participants. The primary end point will be defined as the time from the first dose of study medication to the start of the first 24-hour period without diarrhoea as assessed by the on-duty nurse. Secondary endpoints include the time to cessation of diarrhoea as recorded by parents or guardians in an hourly checklist, stool frequency over the first 3 days, treatment failure, rotavirus and norovirus viral loads, and adverse events.DiscussionThe existing evidence for the use of probiotics in treating acute watery diarrhoea seems to favour their use. However, the size of the effect varies across publications. An array of different probiotic organisms, doses, treatment durations, study populations, designs, settings, and aetiologies have been described. In this trial, we will investigate whether probiotics are beneficial as an adjuvant treatment for children with acute watery diarrhoea in Vietnam, with the aim of guiding clinical practice through improved regional evidence.Trial registrationCurrent Controlled Trials ISRCTN88101063

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Guide to designing, conducting, publishing, and communicating results of clinical studies involving probiotic applications in human participants

Cited by 63 publications

References 63 publications

Documentation of Functional and Clinical Effects of Infant Nutrition: Setting the Scene for COMMENT

Documentation of Functional and Clinical Effects of Infant Nutrition: Setting the Scene for COMMENT

Comparative Study of Efficacy and Safety of Azithromycin Alone and in Combination With Probiotic in the Treatment of Impetigo in Children

An oral preparation of Lactobacillus acidophilus for the treatment of uncomplicated acute watery diarrhoea in Vietnamese children: study protocol for a multicentre, randomised, placebo-controlled trial

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