Efficacy of Lactobacillus reuteri DSM 17938 versus Lactobacillus rhamnosus GG in the management of functional abdominal pain - A Randomised Controlled Trial

Functional Gastrointestinal Disorders (FGIDs) are common in school aged children.The brain-gut axis play a predominant role in the pathophysiology of FGIDs.Probiotics are now emerging to be useful in Functional abdominal pain.Since there is a lack of RCT s involving probiotics in functional abdominal pain in India, we devised a one to determine the efficacy of Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG in the management of functional abdominal pain. Children in the age group of 5 - 12 years will be randomised into two groups with one receiving Lactobacillus reuteri DSM and the other  Lactobacillus rhamnosus GG daily for a period of two months after getting consent and assent from parents and children respectively.Pain intensity will be determined by a validated Wong Baker Faces pain scale which will be taught to parents and children.Baseline pain intensity and pain frequency per month will be marked for each participant before the intervention.Each parent of the trial participant will be given a diary to note the pain intensity using the pain scale and pain frequency daily.The diary will be checked biweekly during the treatment period and monthly during the follow up period of six months.The compliance of probiotic intake will be ensured by the scrutiny of empty probiotic covers brought by the parents and children when they come for review and diary-check.Statistical analysis from the data will be done at the end of treatment period and at the end of follow up period to determine the efficacy of Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG in the reduction of pain intensity and pain frequency. A Likert scale satisfaction survey will be acquired form the parents and children at the end of the follow period of intervention.