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Clinical Trial Finder

Infants Fed an Amino Acid-based Formula

Study Purpose

To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.

Recruitment Criteria

Accepts Healthy Volunteers

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

 No
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.

 Interventional
Eligible Ages N/A - 12 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 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.

Exclusion Criteria:

  • - 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 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.

 NCT04127656
Phase

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.

 N/A
Lead Sponsor

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

 Abbott Nutrition
Principal Investigator

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

 Jan Kajzer, MS, RD, LD
Principal Investigator Affiliation Abbott Nutrition
Agency Class

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

 Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

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

 Food Allergy
Arms & Interventions

Arms

Experimental: Amino Acid-Based Experimental Study Formula

Not commercially available amino acid-based study formula

Interventions

Other: - Amino Acid-Based Experimental Study Formula

Amino acid-based study formula; feed ad libitum

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Adam Practice, Poole, United Kingdom

Status

Suspended

Address

The Adam Practice

Poole, , BH15 4JQ

Southampton, United Kingdom

Status

Recruiting

Address

University Hospital Southampton NHS Foundation Trust

Southampton, , SO16 6YD

Royal London Hospital, Whitechapel, United Kingdom

Status

Recruiting

Address

Royal London Hospital

Whitechapel, , E1 1BB

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