Trials / Unknown
UnknownNCT04358146
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 346 (estimated)
- Sponsor
- United Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Weeks – 4 Months
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
Detailed description
The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional). The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Experimental Infant formula | Exclusive formula feeding with the new infant formula thickened with fibers |
| OTHER | Infant formula thickened with locust bean gum | Exclusive formula feeding with the formula thickened with locust bean |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2022-01-01
- Completion
- 2022-03-01
- First posted
- 2020-04-24
- Last updated
- 2020-04-24
Source: ClinicalTrials.gov record NCT04358146. Inclusion in this directory is not an endorsement.