Trials / Completed
CompletedNCT06083311
The Efficacy of a Probiotic for Functional Constipation (FC)
A Randomised, Triple-blinded, Placebo-controlled, Parallel Group Pilot Study, to Assess the Effect of Probiotic on Functional Constipation and Gut Microbiology
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- The Archer-Daniels-Midland Company · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
Investigate the effect of a probiotic (live bacteria) in individuals with functional constipation.
Detailed description
This study aims to investigate the safety and efficacy of live bacteria on defecation parameters in individuals with Functional Constipation. The trial will be run in Germany and will recruit adult men and women meeting the ROME-IV criteria for functional constipation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic | Participants in this arm will receive a daily dose of 3x10\^9 Colony Forming Units (CFU) of a live bacterium, corresponding to 1 capsules daily for 28 days |
| DIETARY_SUPPLEMENT | Placebo | Participants in this arm will receive an equivalent placebo for 28 days |
Timeline
- Start date
- 2023-10-19
- Primary completion
- 2024-12-17
- Completion
- 2024-12-17
- First posted
- 2023-10-16
- Last updated
- 2025-04-09
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06083311. Inclusion in this directory is not an endorsement.