Trials / Completed
CompletedNCT02598817
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
Acceptability of "High Sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician. An Open Label Pilot Study Evaluation in the Gulf Cooperation Council (GCC) Countries.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 276 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 2 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
Detailed description
This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Standard Infant Formula | Standard Infant Formula containing High Sn-2 |
Timeline
- Start date
- 2018-07-01
- Primary completion
- 2020-01-08
- Completion
- 2021-01-05
- First posted
- 2015-11-06
- Last updated
- 2023-02-24
Locations
5 sites across 2 countries: Saudi Arabia, United Arab Emirates
Source: ClinicalTrials.gov record NCT02598817. Inclusion in this directory is not an endorsement.