Trials / Unknown
UnknownNCT04015089
Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein
Randomized, Parallel, Double-blind Study With a Partially Hydrolyzed Infant Formula With Cow's Milk Protein vs a Formula With Intact Protein to Assess Growth and Impact on the Gastrointestinal Manifestations of Colic in the Healthy Infant.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- Sponsor
- Laboratorios Ordesa · Industry
- Sex
- All
- Age
- 2 Weeks – 8 Weeks
- Healthy volunteers
- Not accepted
Summary
Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic
Detailed description
Demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Partially hydrolyzed formula (pHF) | Infant formula with partially hydrolyzed protein |
| DIETARY_SUPPLEMENT | Standard formula (SF) | Infant formula with intact protein |
Timeline
- Start date
- 2018-07-19
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2019-07-10
- Last updated
- 2020-09-18
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04015089. Inclusion in this directory is not an endorsement.