Infant DevelopmentNCT04575298
Acceptability and Tolerance Study of an Amino Acid Formula with HMOs
An observational study of Infant Development, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Infant Development
- What is being tested?
- Acceptability, tolerance study for an infant formula with human milk oligosaccharides
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2019to 22 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Acceptability, tolerance study for an infant formula with human milk oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptability, tolerance study for an infant formula with human milk oligosaccharidesDietary supplement
Prospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Questionnaire to assess GI symptoms
Measured: Day 7 from baseline
Acceptability
Daily diary measuring volume of formula suggested versus actual formula taken
Measured: Over a 28 days period recorded on a feeding chart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start12 Oct 2019
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Why it stopped: Difficulty to recruit patients due to pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konstantinos Kakleas, Principal investigator, Paediatric allergy consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575298
- Sponsor's protocol ID
- Alfamino with HMOs
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04575298
- Acronym / sponsor ID
- Alfamino with HMOs
- Conditions
- Infant Development
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty to recruit patients due to pandemic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptability, tolerance study for an infant formula with human milk oligosaccharidesProspective study | Dietary supplement | – |
Primary outcome
Gastrointestinal tolerance
Time frame: Day 7 from baseline
Questionnaire to assess GI symptoms
Acceptability
Time frame: Over a 28 days period recorded on a feeding chart
Daily diary measuring volume of formula suggested versus actual formula taken
Results and safety
The study was stopped early (reason given: Difficulty to recruit patients due to pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Kakleas principal investigator
Paediatric allergy consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty to recruit patients due to pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerance (time frame: Day 7 from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.