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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Berberine
Dietary supplementThe study foresees the intake of 3 capsules per day during 8 weeks
Bifidobacterium longum
Dietary supplementThe study foresees the intake of 3 capsules per day during 8 weeks
Bifidobacterium longum and Berberine
Dietary supplementThe study foresees the intake of 3 capsules per day during 8 weeks
Placebo
Dietary supplementThe study foresees the intake of 3 capsules per day during 8 weeks
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: BerberineExperimental treatment 1 intervention
Group B: Bifidobacterium longumExperimental treatment 1 intervention
Group C: Bifidobacterium longum and BerberineExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the intensity and frequency of intestinal symptoms
Comparison between groups in the change from baseline of the intensity and frequency of intestinal symptoms measured by Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS)
Time frame
Throughout the entire study, approximately during 10 months2
Change from baseline in the intensity and frequency of intestinal symptoms
Comparison between groups in the change from baseline of the intensity and frequency of intestinal symptoms measured by Gut symptoms and transit evaluation (GSTE)
Time frame
Throughout the entire study, approximately during 10 monthsSecondary outcomes
1
Change from baseline in the intestinal-related quality of life
Comparison between groups in the change from baseline of intestinal-related quality of life, measured by the Irritable Bowel Syndrome - Quality of life (IBS-QoL) questionnaire
Time frame
Throughout the entire study, approximately during 10 months2
Change from baseline in the intestinal permeability
Comparison between groups in the change from baseline of the intestinal permeability, measured by plasma level of LBP
Time frame
Throughout the entire study, approximately during 10 months3
Change from baseline in the microbiota composition
Comparison between groups of the change from baseline in the microbiota composition, assessed using DNA extraction followed by high-throughput sequencing of the 16S rRNA gene
Time frame
Throughout the entire study, approximately during 10 months4
Product satisfaction
Comparison between groups in product satisfaction (5-point Likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied)
Time frame
Throughout the entire study, approximately during 10 monthsSponsors and contacts
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Source ClinicalTrials.gov