Efficacy of a New Infant Formula Composition on Gut Health in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Infant Formula, Infant Formula with bioactive ingredients.
- Who it may be relevant to
- Registry conditions: Healthy Infants. Basic parameters: 0 Days — 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of a New Infant Formula Composition on Gut Health in Infants: A Prospective Randomized Double-blind Placebo-controlled Trial
Overview
The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored
Interventions
- Other Infant Formula
ad-libitum consumption of infant formula - Other Infant Formula with bioactive ingredients
ad-libitum consumption
Primary outcome measures
- Bifidobacterium [Time frame: From enrollment to the end of treatment at 10 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07242508 · ECCT2831