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Not Yet RecruitingNCT07420231

Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
Université Catholique de Louvain · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

This study is designed as a randomized double-blind placebo-controlled interventional study. One hundred and forty individuals aged between 18 and 75 years and experiencing a measurable level of intestinal discomfort will be randomly allocated to one of the four groups (35 subjects per group): control, prebiotic only, postbiotic only, or combination of both. Subjects will receive their assigned supplementation for 8 weeks. Intestinal discomfort will be measured through tests and questionnaires at baseline, mid-intervention (week 4), at the end of intervention (week 8), and after a follow-up period of 4 weeks (week 12).

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTBerberineThe study foresees the intake of 3 capsules per day during 8 weeks
DIETARY_SUPPLEMENTBifidobacterium longumThe study foresees the intake of 3 capsules per day during 8 weeks
DIETARY_SUPPLEMENTBifidobacterium longum and BerberineThe study foresees the intake of 3 capsules per day during 8 weeks
DIETARY_SUPPLEMENTPlaceboThe study foresees the intake of 3 capsules per day during 8 weeks

Timeline

Start date
2026-02-24
Primary completion
2026-10-24
Completion
2026-12-24
First posted
2026-02-19
Last updated
2026-02-23

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT07420231. Inclusion in this directory is not an endorsement.