Formula Tolerance of Term Infants

Gastro-Intestinal Tolerance Clinical Trial

Official title:

Tolerance of Term Infants Fed Formula With Oligosaccharides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915937
• Other study ID #: AL41
• Status: Completed
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: December 2022
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Days to 65 Days

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastro-Intestinal Tolerance

Intervention

Other:
• Study Infant Formula
RTF milk-based infant formula with oligosaccharides

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Formula Intake	Parent Completed Diary	SDAY 1 to SDAY 28
Other	Weight	Weight gains, percentiles, and z-scores	SDAY 1 to SDAY 28
Other	Length	Length gains, percentiles, and z-scores	SDAY 1 to SDAY 28
Other	Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from frequent to less frequent	SDAY 1 and SDAY 28
Other	Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories scaled from positive to negative	SDAY 1 and SDAY 28
Other	Parental perspectives	Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive	SDAY 1 and SDAY 28
Other	Health Resource Utilization	Number of Visits	SDAY 7 and SDAY 28
Other	Adverse Events	Standard adverse event reporting	SDAY 1 to SDAY 28
Primary	Fussiness	Absolute and % change in fussiness severity reported from Daily Tolerance Diary	Baseline to Study Day (SDAY) 2
Secondary	Gastrointestinal Tolerance	Parent Completed Diary	Baseline to SDAY 28
Secondary	Stool	Parent Completed Diary	Baseline to SDAY 28