Acceptability and Tolerance Study of an Amino Acid Formula with HMOs

Terminated

• Conditions: Infant Development

• Registration Number: NCT04575298
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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

Study Timeline

• Study Start: 2019-10-12
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients well established and stable on Alfamino (or another amino acid formula dependent on feasibility of reaching required numbers) for the dietary management of presumed CMA (no gastrointestinal intolerances on current formula).

Full term infants less than 12 months of age where the amino acid formula is still the sole source of nutrition. Full term infants less than 12 months of age where the amino acid formula is required for 1 week to measure GI tolerance and 1 week of exclusive HMO amino acid formula intake. Thereafter formula intake data will be collected for the remaining 3 weeks and the child can be weaned at this stage.

iWillingly given, written, informed consent from patient or parent/guardian.

Exclusion Criteria

Partially or fully Breastfed infants. Inability to comply with the study protocol, in the opinion of the investigator.

Previously not tolerated Alfamino without HMOs. More than 12 months old Need an amino acid formula as supplementary use Patients with significant renal or hepatic impairment Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator e.g. thickener, PPIs etc (must be recorded in patient case record file).

Participation in another interventional study within 2 weeks of this study. Introduction of complementary feeding during the study period Caregiver unable to read and write in English (will need to complete 7 1 monthdays of forms at home).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	Day 7 from baseline	Questionnaire to assess GI symptoms
Acceptability	Over a 28 days period recorded on a feeding chart	Daily diary measuring volume of formula suggested versus actual formula taken

Trial Locations

Locations (1)

Children's Research Team; 🇬🇧 Leicester, United Kingdom