RECRUITING

Goat or Cow Milk Based Infant Formula GMS

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula

Quick Facts

Study Start:2023-12-14

Study Completion:2024-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06312059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 14 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Luke Douglas

CONTACT

+44 (0)7950211990

Luke.Douglas@KendalNutricare.com

Will McMahon

CONTACT

+44( 0)7484056316

Will.McMahon@kendamil.com

Principal Investigator

Allan Soo

PRINCIPAL_INVESTIGATOR

MD, FAPCR ObvioHealth USA, Inc.

Study Locations (Sites)

ObvioHealth USA, Inc.

New York, New York, 10001

United States

Collaborators and Investigators

Sponsor: Kendal Nutricare Ltd

Allan Soo, PRINCIPAL_INVESTIGATOR, MD, FAPCR ObvioHealth USA, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-14

Study Completion Date2024-08-15

Study Record Updates

Study Start Date2023-12-14

Study Completion Date2024-08-15

Terms related to this study

Additional Relevant MeSH Terms

Growth