AL28 Abbott Nutrition
Research type
Research Study
Full title
Symptom Changes in Infants Fed an Amino Acid Based Formula
IRAS ID
246531
Contact name
Michel Erlewyn-Lajeunesse
Contact email
Sponsor organisation
Abbott Nutrition
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
Does feeding an amino acid-based formula reduce or resolve symptoms associated with cow’s milk protein allergy, multiple food allergies, food protein-induced enterocolitis and/or gastrointestinal eosinophilic disorders?
Formula fed infants, between 0 and 12 months of age, who have been documented with cow’s milk protein allergy, other food allergies, or gastrointestinal eosinophilic disorders with symptoms including regurgitation, constipation, diarrhoea, blood in the stool, crying, wind, and/or skin rash will be recruited by the investigators from their local populations. All infants will be on the sample study product at about 3 centers in the UK.
Informed consent will be obtained prior to enrolment. Weight and length, demographic data, clinical history and a baseline tolerance questionnaire will be collected. Study formula will be provided. Daily tolerance symptom diaries along with daily intake and stool records will be completed for 4 weeks.
Parent(s) confirm intention to feed their infant study product during the study period. At least 200 mLs of study formula must be consumed each day. No other formula or human milk should be consumed by any subject. Solid foods may be introduced during the study, if deemed appropriate by their physician. If solid foods were introduced when infant is enrolled, they can continue consuming those foods and additional foods may be introduced during the study, if recommended by their physician.
Subjects using medications (including over-the-counter medication) or home remedies, herbal preparations, prebiotics, probiotics, or rehydration fluids that might affect their tolerance may not be enrolled unless the parent agrees to stop the use of these items before enrolment or a healthcare professional recommends their continued use.
At exit, anthropoemetrics, history information and questionnaires will be obtained, along with collection of parent records. If subjects need an amino acid-based formula upon study exit, study formula will be provided until formula becomes commercially available.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0035
Date of REC Opinion
7 Jun 2019
REC opinion
Further Information Unfavourable Opinion