Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversité Catholique de Louvain
About this trial
This study aims to investigate the beneficial effects of the daily consumption of a synbiotic formulation-combining a prebiotic (Berberine, BBR) and a postbiotic (inactivated Bifidobacterium Longum, B.longum)-in adults experiencing intestinal discomfort.
Eligibility criteria
Qualifiers
Woman or man, aged of 18 to 75 years (inclusive);
Experience recurrent abdominal pain present for at least three months and occurring on a regular basis;
The abdominal discomfort must have a low to moderate impact on quality of life;
Diarrhea
Disqualifiers
Subject with severe or chronic medical conditions which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study outcomes or compromise participant safety;
Subject with a diagnosed gastrointestinal disorder (e.g., Crohn's disease, inflammatory bowel disease, or other chronic digestive conditions);
Subject with type 1 or type 2 diabetes;
Subject who has taken, within the 28 days prior to the screening visit, or are currently taking, drugs or food supplements intended to improve intestinal comfort, or any other substances that, in the opinion of the Principal Investigator, could interfere with intestinal comfort assessment or transit frequency (prebiotics, laxative, anti-diarrheal, probiotics, postbiotics, synbiotics). These products will also be avoided for the duration of the study;
Trial design
Treatments tested in this trial
- Berberine
- Bifidobacterium longum
- Bifidobacterium longum and Berberine
- Placebo
Treatment groups
140 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov