Tolerance of Infants Fed a Hydrolysate Formula
Completed · Not applicable
Conditions studied: Gastrointestinal Tolerance
In brief
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
Key facts
- Study ID
- NCT03628183
- Run by
- Abbott Nutrition
- People needed
- 51
- Starts
- 2018-08-28
- Expected to finish
- 2018-11-23
- Last updated by the study team
- 2018-12-19
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject is judged to be in good health
- Singleton from a full-term birth
- Birth weight was > or = to 2490 g
- Between 0 and 14 days of age at enrollment
- Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study
- Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
- Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)
You may not qualify if…
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Subject participates in another study that has not been approved as a concomitant study
- Subject has an allergy or intolerance to any ingredient in the study product
- Subject has been treated with antibiotics within 2 weeks prior to enrollment
Where it is running
- Watching Over Mothers and Babies — Tucson, Arizona, United States
- Springs Medical Research — Owensboro, Kentucky, United States
- The Cleveland Pediatric Research Center, LLC — Cleveland, Ohio, United States
- Institute of Clinical Research, LLC — Mentor, Ohio, United States
- Midsouth Center for Clinical Research — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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