Acceptability and Tolerance Study of an Amino Acid Formula with HMOs

NCT04575298 | Terminated DMC

• 1 other identifier: Alfamino with HMOs
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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

Prospective study

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Children's Research Team

Leicester, LE1 5WW, United Kingdom

Location

Study Officials

• Konstantinos Kakleas

  Paediatric allergy consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: October 5, 2020
• Study Start: October 12, 2019
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

GB (1)