Trials / Recruiting
RecruitingNCT07190859
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- BioGaia AB · Industry
- Sex
- All
- Age
- 3 Weeks – 12 Weeks
- Healthy volunteers
- Not accepted
Summary
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | L. reuteri | Supplementation with drops containing L. reuteri once daily for 21 consecutive days |
| DIETARY_SUPPLEMENT | Placebo | Supplementation with identical drops without L. reuteri once daily for 21 consecutive days |
Timeline
- Start date
- 2025-08-04
- Primary completion
- 2026-02-17
- Completion
- 2026-08-30
- First posted
- 2025-09-24
- Last updated
- 2025-09-24
Locations
4 sites across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT07190859. Inclusion in this directory is not an endorsement.