Trials / Terminated
TerminatedNCT04575298
Acceptability and Tolerance Study of an Amino Acid Formula with HMOs
To Evaluate the Acceptability, Gastrointesinal Tolerance and Compliance of a Hypoallergenic Powdered Amino Acid Infant Formula with HMOs for the Dietary Management of Cows' Milk Allergy (CMA) and Multiple Food Allergies.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 1 Month – 12 Months
- Healthy volunteers
- Not accepted
Summary
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with HMOs for the dietary management of cows' milk allergy in infants less than 12 months of age.
Detailed description
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a 7-day period, of Amino acid formula with HMOs, which is a hypoallergenic amino acid for infant formula for the dietary management of cows' milk allergy. The acceptability data from a minimum of 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the HSE for the Ireland to be reimbursed under the GMS and community drug schemes
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Acceptability, tolerance study for an infant formula with human milk oligosaccharides | Prospective study |
Timeline
- Start date
- 2019-10-12
- Primary completion
- 2020-12-22
- Completion
- 2020-12-22
- First posted
- 2020-10-05
- Last updated
- 2024-10-15
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04575298. Inclusion in this directory is not an endorsement.