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Acceptability and Tolerance Study of an Amino Acid Formula With HMOs

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 1 Month - 12 Months
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Konstantinos Kakleas
Principal Investigator Affiliation Paediatric allergy consultant
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Infant Development
Additional Details

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

Contact a Trial Team

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International Sites

Children's Research Team, Leicester, United Kingdom




Children's Research Team

Leicester, , LE1 5WW

Site Contact

konstantinos Kakleas


0116 258 6907

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