Acceptability and Tolerance Study of an Amino Acid Formula with HMOs

NCT ID: NCT04575298

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-12
• Study Completion Date: 2020-12-22

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

Conditions

Infant Development

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Acceptability, tolerance study for an infant formula with human milk oligosaccharides

Prospective study

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konstantinos Kakleas

Role: PRINCIPAL_INVESTIGATOR

Paediatric allergy consultant

Locations

Children's Research Team

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

Alfamino with HMOs

Identifier Type: -

Identifier Source: org_study_id