Food AllergyNCT04127656
Infants Fed an Amino Acid-based Formula
A study testing Amino Acid-Based Experimental Study Formula in people with Food Allergy, run by Abbott Nutrition at 3 sites in United Kingdom.
Trial summary
To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Food Allergy
- What is being tested?
- Amino Acid-Based Experimental Study Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 16 Dec 2019to 16 Dec 2021
- Phase
- Interventional
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is judged to be in good health as determined from subject's medical history
- Subject is from a full-term birth with a gestational age of 37-42 weeks
- Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- Subject has been documented to have CMPA and/or multiple food allergies, FPIES or gastrointestinal eosinophilic disorders.
- Subject is experiencing persistent feeding intolerance symptoms including any of the following: regurgitation/vomiting associated with feeding (within 1 hour), constipation, diarrhoea, hematochezia (blood in the stool), crying, gassiness (wind), and/or skin rash/eczema.
- Parent(s) confirm their intention to feed their infant study product during the study period.
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- Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrolment through the duration of the study, unless instructed otherwise by their healthcare professional.
- Infant using medications (OTC medications for gas [wind]), home remedies (such as juice for constipation), herbal preparations, prebiotics, probiotics or rehydration fluids that might affect Gl tolerance may not be enrolled unless the parent agrees to discontinue the use of these agents prior to enrolment or a healthcare professional recommends their continued use.
- Subject's parent(s) has voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy regulation authorisation prior to any participation in the study.
Who cannot join
- Subject is receiving steroids or antibiotics
- Subject is tube-fed
- Subject has received an amino acid-based formula
- Subject has been diagnosed with: Short bowel syndrome, Inflammatory bowel disease, Pancreatic disease, Protein maldigestion (malnutrition), Mast cell disorder
- Subject is participating in another study that has not been approved as a concomitant study by AN
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
The Adam Practice
Poole, BH15 4JQ
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Royal London Hospital
Whitechapel, E1 1BB
About this study
Official title: Symptom Changes in Infants Fed an Amino Acid-based Formula
To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.
- Conditions
- Food Allergy
- Being tested
- Amino Acid-Based Experimental Study Formula
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid-Based Experimental Study FormulaOther
Amino Acid-Based Formula; fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid-Based Experimental Study Formula | Experimental | Single-Arm Study Receives: Other: Amino Acid-Based Experimental Study Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Allergy Symptom Improvement
Parent Completed Symptom Diary
Measured: Baseline to Day 28
Secondary outcomes (4)
Time to Symptom Resolution or Reduction
Parent Completed Symptom Diary
Measured: Baseline to Day 28
Change in Length
Length-for-age z scores
Measured: Baseline to Day 28
Change in Weight
Weight-for-age z scores
Measured: Baseline to Day 28
Study Formula Intake
Parent Completed Intake Diary
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start16 Dec 2019
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Kajzer, MS, RD, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127656
- Sponsor's protocol ID
- AL28
- Status last verified
- Apr 2022
- First submitted
- 11 Oct 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Changes in Infants Fed an Amino Acid-based Formula
- ClinicalTrials.gov ID
- NCT04127656
- Acronym / sponsor ID
- AL28
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 15 Oct 2019 (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 observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amino Acid-Based Experimental Study Formula | Experimental | Other: Amino Acid-Based Experimental Study FormulaSingle-Arm Study |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Subject is judged to be in good health as determined from subject's medical history
- Subject is from a full-term birth with a gestational age of 37-42 weeks
- Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- Subject has been documented to have CMPA and/or multiple food allergies, FPIES or gastrointestinal eosinophilic disorders.
- Subject is experiencing persistent feeding intolerance symptoms including any of the following: regurgitation/vomiting associated with feeding (within 1 hour), constipation, diarrhoea, hematochezia (blood in the stool), crying, gassiness (wind), and/or skin rash/eczema.
Key exclusion criteria (5 listed)
- Subject is receiving steroids or antibiotics
- Subject is tube-fed
- Subject has received an amino acid-based formula
- Subject has been diagnosed with: Short bowel syndrome, Inflammatory bowel disease, Pancreatic disease, Protein maldigestion (malnutrition), Mast cell disorder
- Subject is participating in another study that has not been approved as a concomitant study by AN
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 |
|---|---|---|
| Amino Acid-Based Experimental Study FormulaAmino Acid-Based Formula; fed ad libitum | Other | Amino Acid-Based Experimental Study Formula |
Primary outcome
Food Allergy Symptom Improvement
Time frame: Baseline to Day 28
Parent Completed Symptom Diary
4 secondary outcomes
Time to Symptom Resolution or Reduction
Time frame: Baseline to Day 28
Change in Length
Time frame: Baseline to Day 28
Change in Weight
Time frame: Baseline to Day 28
Study Formula Intake
Time frame: Baseline to Day 28
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Jan Kajzer, MS, RD, LD study chair
Abbott Nutrition
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid-Based Experimental Study Formula in people with Food Allergy, run by Abbott Nutrition at 3 sites 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 9 inclusion and 5 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: Insufficient recruitment). 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?
Food Allergy Symptom Improvement (time frame: Baseline to Day 28). 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 27 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.