Formula Tolerance of Term Infants

Completed · Not applicable

Conditions studied: Gastro-Intestinal Tolerance

In brief

To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants

Key facts

Study ID

NCT04915937

Run by

Abbott Nutrition

People needed

45

Starts

2021-07-13

Expected to finish

2022-11-22

Last updated by the study team

2022-12-20

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant is judged to be in good health as determined from participant's medical history by parent report
• Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
• Participant's birth weight was >= 2490 g (\~5 lbs. 8 oz.)
• Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
• Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
• Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
• Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local privacy regulation authorization prior to any participation in the study

You may not qualify if…

• An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse.
• Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
• Participant participates in another study that has not been approved as a concomitant study
• Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
• Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
• Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
• Participant has been treated with antibiotics within 7 days prior to enrollment

Where it is running

• MedPharmics, LLC — Phoenix, Arizona, United States
• Dade Research Center, LLC — Miami, Florida, United States
• Meridian Clincial Research- Macan — Macon, Georgia, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Springs Medical Research — Owensboro, Kentucky, United States
• MedPharmics — Covington, Louisiana, United States
• Boeson Research Kalispell — Kalispell, Montana, United States
• Meridian Clinical Research — Hastings, Nebraska, United States
• Be Well Clinical Studies — Lincoln, Nebraska, United States
• AVIATI Healthcare & Clinical Research — Memphis, Tennessee, United States
• Invesclinic US LLC — Edinburg, Texas, United States
• Maximos Ob/Gyn — League City, Texas, United States

Full record on ClinicalTrials.gov

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