Trials / Not Yet Recruiting
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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Berberine | The study foresees the intake of 3 capsules per day during 8 weeks |
| DIETARY_SUPPLEMENT | Bifidobacterium longum | The study foresees the intake of 3 capsules per day during 8 weeks |
| DIETARY_SUPPLEMENT | Bifidobacterium longum and Berberine | The study foresees the intake of 3 capsules per day during 8 weeks |
| DIETARY_SUPPLEMENT | Placebo | The 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.