IBS Research and Probiotics
Executive Summary Irritable bowel syndrome (IBS) is characterized bychronicabdominal pain, discomfort, bloating, and alteration of bowel habits and affects 10- 15% of the general population. In this work, we utilised two well-characterised strains. Each strain has interesting properties related to IBS. The first one has been shown to attenuate the anxiety and stress and improving cognition in preclinical and clinical studies. The second strain has been extensively studied and shown to regulate inflammatory responses and reduce abdominal pain, bloating, gas and unpredictable bowel habits in IBS subjects in two well-controlled clinical studies. Therefore, the aim of this trial is to investigate the effect of a combination of both on bowel symptoms and stress/mood in adults with IBS. The research project consisted of 2 phases: 1) a pilot study and 2) a randomized, double-blind, placebo- controlled crossover study. Challenges and Objectives
Atlantia first performed a pilot study to estimate the carryover effect and determine the washout period required for the randomized, double- blind, placebo-controlled crossover study and provide preliminary data on the subject characteristics and variation in the parameters measured.
The primary objective was to assess the impact of the investigational product on stress and mood in adults with IBS as determined by change in HADs score. Other objectives were to assess the impact of the investigational product on IBS symptoms, on abdominal pain/discomfort, and on individual symptoms such as Stool frequency, Stool consistency (Bristol Stool Scale), Abdominal pain/ discomfort, Abdominal bloating/distension, Bowel movement urgency, Straining and Passage of gas. The safety of the investigational product was evaluated throughout the study on the basis of serious and non-serious adverse events and safety parameters. The main challenge was to ensure that an intervention from one period did not have a residual effect that persisted into the subsequent period in a cross-over design. This is called a carryover effect. A technical team with the expertise on these type of designs was required.
atlantiaclinicaltrials.com
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