Trials / Terminated
TerminatedNCT02221687
The Combiotic-Study
Evaluation of the Efficacy and Safety of an Infant Formula Containing Synbiotics and Its Effects on the Incidence of Infectious Diseases in the Infant Gut : a Double-blind, Randomized, Controlled Interventional Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 540 (actual)
- Sponsor
- HiPP GmbH & Co. Vertrieb KG · Industry
- Sex
- All
- Age
- 3 Weeks – 5 Weeks
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Synbiotic formula | Standard milk formula enriched with a prebiotic fiber and a probiotic strain |
| DIETARY_SUPPLEMENT | Control formula | Standard milk formula without pre and probiotic |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2019-04-01
- Completion
- 2021-04-01
- First posted
- 2014-08-20
- Last updated
- 2022-01-20
Locations
25 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02221687. Inclusion in this directory is not an endorsement.