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.

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.

Study Overview

• Status: Terminated
• Conditions: Infant Development
• Intervention / Treatment: Dietary supplement: Acceptability, tolerance study for an infant formula with human milk oligosaccharides

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • Children's Research Team

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Konstantinos Kakleas, Paediatric allergy consultant

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2019
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): December 22, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Alfamino with HMOs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No