Trials / Completed
CompletedNCT06462651
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
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- 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
- 2025-06-09
- Primary completion
- 2026-03-15
- Completion
- 2026-03-15
- First posted
- 2024-06-17
- Last updated
- 2026-03-19
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06462651. Inclusion in this directory is not an endorsement.