Clinical trial NCT06312059: Goat or Cow Milk Based Infant Formula GMS
Official title: Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Growth
Lead sponsor: Kendal Nutricare Ltd
Sponsor class: INDUSTRY
Collaborators: name: ObvioHealth
First posted: 2024-03-15
Enrollment: 264
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).


Eligibility criteria: Inclusion Criteria:

1. Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator
2. Infants with a birth weight of \>2500 g to \<4500 g
3. Infants ≤11 days of age at enrollment; birth constitutes Day 0
4. Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study

Exclusion Criteria:

A participant who meets any of the following criteria will be excluded from participation in the study:

1. Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
2. Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
3. Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
4. Infant that has received oral or parenteral antibiotics prior to enrollment
5. Infant is taking and parent/legal guardian plans to continue (including over-the-counter medications, such as Mylicon® for gas), home remedies (such as juice for constipation), gastroesophageal reflux medications, herbal preparations, or rehydration fluids that, in the Investigator's opinion, might affect gastrointestinal tolerance. Use of the following are strongly discouraged for the duration of the trial:

   1. Solid foods and juices
   2. Vitamins and/mineral supplements, as the study product provided is nutritionally complete
   3. Pre- and probiotics
6. Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)
7. Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.

Primary outcomes:
measure: Growth as compared against WHO growth charts
timeFrame: 16 weeks
Secondary outcomes:
measure: Safety
timeFrame: 16 weeks
Other outcomes:
measure: Tolerability- Monitoring of stool consistency
timeFrame: 16 weeks
measure: Tolerability - fussiness
timeFrame: 16 weeks
measure: Mean Daily Recumbent Length Gain
timeFrame: 16 weeks
measure: Mean Daily Head Circumference Gain
timeFrame: 16 weeks
Locations:
city: New York
country: United States
facility: ObvioHealth USA, Inc.
state: New York
Study officials:
affiliation: MD, FAPCR ObvioHealth USA, Inc.
name: Allan Soo
role: PRINCIPAL_INVESTIGATOR
References: