Trials / Completed
CompletedNCT03449628
L. Casei DG® in Patients With Irritable Bowel Syndrome.
L. Casei DG® (Lactobacillus Paracasei CNCMI1572) in the Treatment of Patients With Irritable Bowel Syndrome: a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- SOFAR S.p.A. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | L.casei DG | (At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks |
| DIETARY_SUPPLEMENT | PLACEBO | 1 capsule, b.i.d. for 12 weeks |
Timeline
- Start date
- 2017-11-06
- Primary completion
- 2021-05-04
- Completion
- 2021-12-30
- First posted
- 2018-02-28
- Last updated
- 2022-05-06
Locations
20 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03449628. Inclusion in this directory is not an endorsement.