Effect of a New Infant Formula on Gut Health in Healthy Infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares an experimental infant formula with a standard formula in healthy full-term infants who are not breastfed. The main goal is to see if the experimental formula raises the relative amount of Bifidobacterium in stool after 10 weeks. Researchers will also monitor stool characteristics and other gut health symptoms. Infants will be exclusively fed the assigned formula for the study duration. The study is sponsored by FrieslandCampina and is conducted at a site in Sofia, Bulgaria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy, full term, infants with a birth weight between 2500-4500 grams
* Parents independently from study decided to not breastfeed their infant
* Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
* have read and voluntarily signed an informed consent form
* parents are capable of completing study procedures required by the protocol

Exclusion Criteria:

* suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding
* are required to take medications or supplements known to influence growth and development
* have a maternal history with known adverse effects on the fetus and/or the newborn infant
* have previous or current antibiotics use (antibiotics administered during delivery are permitted)
* have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)
* personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance
* multiple birth
* participation in another trial

Where it's running

• Second SAGBAL Sheinovo AD
  Sofia, Bulgaria Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.