Clinical trial NCT04915937: Formula Tolerance of Term Infants
Official title: Tolerance of Term Infants Fed Formula With Oligosaccharides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2021-06-07
Enrollment: 45
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 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 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

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 and SDAY 28
measure: Formula Satisfaction Questionnaire
timeFrame: SDAY 1 and SDAY 28
measure: Parental perspectives
timeFrame: SDAY 1 and SDAY 28
measure: Health Resource Utilization
timeFrame: SDAY 7 and SDAY 28
measure: Adverse Events
timeFrame: SDAY 1 to SDAY 28
Locations:
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Miami
country: United States
facility: Dade Research Center, LLC
state: Florida
city: Macon
country: United States
facility: Meridian Clincial Research- Macan
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Covington
country: United States
facility: MedPharmics
state: Louisiana
city: Kalispell
country: United States
facility: Boeson Research Kalispell
state: Montana
city: Hastings
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: Memphis
country: United States
facility: AVIATI Healthcare & Clinical Research
state: Tennessee
city: Edinburg
country: United States
facility: Invesclinic US LLC
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Elizabeth Reverri, PhD, MS, RD
role: STUDY_CHAIR
References: