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| Name | Class |
|---|---|
| ObvioHealth | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Market leader- Competitor Cow Milk based infant formula | Active Comparator | Intervention with Competitor product currently in market- Control. |
|
| Test product Cow Milk based infant formula | Experimental | Intervention with Test product product - Test arm. |
|
| Test product Goat Milk based infant formula | Experimental | Intervention with Test product product - Test arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advance Infant Formula Powder | Other | Sole source infant nutrition for the control arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth as compared against WHO growth charts | Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse Events reported over the 16-week study period (+4 days) for all groups | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability- Monitoring of stool consistency | • Stool characteristics (using BITSS) at baseline, and Weeks 2, 4, 8, 12, and 16 | 16 weeks |
| Tolerability - fussiness | • Formula tolerance (using IGSQ) at baseline, and Weeks 2, 4, 8, 12, and 16 |
Inclusion Criteria:
Exclusion Criteria:
A participant who meets any of the following criteria will be excluded from participation in the study:
Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
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
Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
Infant that has received oral or parenteral antibiotics prior to enrollment
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:
Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)
Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Allan Soo | MD, FAPCR ObvioHealth USA, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ObvioHealth USA, Inc. | New York | New York | 10001 | United States |
Information to be shared with regulatory agencies.
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RP Over stickered TP in blank packaging.
| "Kendamil Cow milk test product | Other | Sole source infant nutrition for the cow milk test arm. |
|
| "Kendamil goat milk test product | Other | Sole source infant nutrition for the goat milk test arm. |
|
| 16 weeks |
| Mean Daily Recumbent Length Gain | Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in: o mean daily recumbent length gain | 16 weeks |
| Mean Daily Head Circumference Gain | Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in: o mean daily head circumference gain | 16 weeks |