Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
264 participants
INTERVENTIONAL
2023-12-14
2024-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Market leader- Competitor Cow Milk based infant formula
Intervention with Competitor product currently in market- Control.
Advance Infant Formula Powder
Sole source infant nutrition for the control arm.
Test product Cow Milk based infant formula
Intervention with Test product product - Test arm.
"Kendamil Cow milk test product
Sole source infant nutrition for the cow milk test arm.
Test product Goat Milk based infant formula
Intervention with Test product product - Test arm.
"Kendamil goat milk test product
Sole source infant nutrition for the goat milk test arm.
Interventions
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Advance Infant Formula Powder
Sole source infant nutrition for the control arm.
"Kendamil Cow milk test product
Sole source infant nutrition for the cow milk test arm.
"Kendamil goat milk test product
Sole source infant nutrition for the goat milk test arm.
Eligibility Criteria
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Inclusion Criteria
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
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.
14 Days
ALL
Yes
Sponsors
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ObvioHealth
INDUSTRY
Kendal Nutricare Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Allan Soo
Role: PRINCIPAL_INVESTIGATOR
MD, FAPCR ObvioHealth USA, Inc.
Locations
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ObvioHealth USA, Inc.
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KNC-GMS-002
Identifier Type: -
Identifier Source: org_study_id
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