Acceptability and Tolerance Study of an Amino Acid Formula With HMOs

Infant Development Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04575298
• Other study ID #: Alfamino with HMOs
• Status: Terminated
• Start date: October 12, 2019
• Est. completion date: December 22, 2020

Study information

• Verified date: January 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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).

Related Conditions & MeSH terms

• Infant Development

Intervention

Dietary Supplement:
• Acceptability, tolerance study for an infant formula with human milk oligosaccharides
Prospective study

Locations

Country	Name	City	State
United Kingdom	Children's Research Team	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United Kingdom, 

Outcome

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