Clinical trial NCT04934397: Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula
Official title: Tolerance in Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula With Oligosaccharides
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastro-Intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2021-06-22
Enrollment: 18
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To assess the effects of partially hydrolyzed whey protein-based infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants.


Eligibility criteria: 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 is identified by parents as very fussy or extremely fussy on current formula in the Baseline Tolerance Evaluation
* 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) of participants confirm their intention not to administer vitamin, mineral, human milk oligosaccharides (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 Health Insurance Portability and Accountability Act (HIPAA) (or other applicable 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 containing greater than two HMOs prior to study enrollment.
* Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to enrollment and/or 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
* Participant has been treated with antibiotics within 7 days prior to enrollment

Primary outcomes:
measure: Fussiness
timeFrame: Baseline to Study Day (SDAY) 2
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Baseline to SDAY 28
measure: Stool
timeFrame: Baseline to SDAY 28
Other outcomes:
measure: Formula Intake
timeFrame: SDAY 1 to SDAY 28
measure: Weight
timeFrame: SDAY 1 to SDAY 28
measure: Length
timeFrame: SDAY 1 to SDAY 28
measure: Infant Feeding and Stool Patterns Questionnaire
timeFrame: SDAY 1 to SDAY 28
measure: Formula Satisfaction Questionnaire
timeFrame: SDAY 1 to SDAY 28
measure: Parental Perspectives
timeFrame: SDAY 1 to SDAY 28
measure: Health Resource Utilization
timeFrame: SDAY 1 to SDAY 28
measure: Adverse Events
timeFrame: SDAY 1 to SDAY 28
Locations:
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Spring Hill
country: United States
facility: ASCLEPES Research Centers
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Covington
country: United States
facility: MedPharmics
state: Louisiana
city: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Mentor
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Memphis
country: United States
facility: AVIATI Healthcare & Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: Midsouth Center for Clinical Research
state: Tennessee
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Webster
country: United States
facility: Clear Lake Specialties
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: John Lasekan, PhD, MS, MBA, CCRP
role: STUDY_CHAIR
References: