NCT01874301

Probiotics and Gut Health

Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Probiotic Food Product in Adults With Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Gastrointestinal discomfort regularly affects \>25% of the population worldwide. One of the major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of \~15%, and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel. Previous studies have shown that probiotics improve colonic transit times in constipated patients. In addition, several other studies, employing a range of different probiotic strains, have shown a significant increase in defaecation frequency and improvement in stool consistency. However, the clinical relevance of these results is uncertain, due to small sample sizes and limitations in study methodology. The current study is designed to compare changes in gut transit time and gastrointestinal symptoms following 4 weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled manner, in adults with constipation.

Detailed description

This is an adaptive, parallel, double-blinded, randomized, placebo-controlled, stratified clinical study, comparing three study arms (two quantities of the probiotic active component and one placebo)with equal allocation ratio. Recruitment of subjects to the low quantity of the probiotic will be after fulfilling certain criteria at interim. After half of the subjects in the two study groups of high quantity and placebo have completed the study (40 subjects), an interim analysis will be performed. Depending on the observed effect size and the conditional power, the study may be stopped for futility, continued with the two groups or continued with inclusion of the third group of low dose probiotics.

Conditions

• Constipation

Interventions

Type	Name	Description
OTHER	High quantity probiotic	The intervention type is food product
OTHER	Low quantity probiotic	The intervention type is food product
OTHER	placebo

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-06-11
• Last updated: 2015-11-10

Locations

1 site across 1 country: United Kingdom