Efficacy of a Dietary Supplement in Infants

Starting soon · Not applicable · Has a placebo group

Conditions studied: Healthy Infants

In brief

This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement.

Key facts

Study ID

NCT07341477

Run by

Société des Produits Nestlé (SPN)

People needed

172

Starts

2026-06-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR])
• Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity
• Parent(s) / LAR(s) must understand the informed consent form and other study documents
• Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol including infant blood collection
• Parent(s) / LAR(s) can be contacted directly by telephone throughout the study
• Parent(s) / LAR(s) must be able to temporarily store stool samples in a household freezer
• Parent(s) / LAR(s) of formula-fed infants (either exclusively or mixed-fed) must have previously and independently decided to use formula and their infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment
• Infant must be healthy based on medical history and physical examination
• Infant full-term gestational birth (born 37 weeks, 0 days through 41 weeks, 6 days)
• Infant age 5 months ± 1 week (date of birth = day 0) at time of clinic visit 1
• Infant birth weight is appropriate for gestational age (i.e., ≥ 2500 and ≤ 4500 grams)

You may not qualify if…

• Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
• Infants receiving solid foods or liquids other than breastmilk or infant formula within 4 weeks prior to enrollment
• Infants who have a medical condition or medical history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
• Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)
• Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
• Immunocompromised infants and those who have a central venous catheter
• History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy.
• Known or suspected allergy to milk (including lactose) or soy
• Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
• Infants who are currently receiving or who have received any probiotic supplements or any infant formula containing probiotics prior to enrollment
• Infants who are currently receiving or who have previously received any of the following medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes), stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose), growth (e.g. insulin or growth hormone), microbiome-related endpoints (e.g., prebiotic supplements, antibiotic usage within the past 4 weeks [not including topical or ophthalmic applications]), or gastric acid secretion.
• Infants whose parent(s) / LAR(s) have not reached the legal age of majority (18 years old)
• Infants who are currently or who previously participated in another interventional clinical study
• Parent(s) / LAR(s) with family or hierarchical relationships with the research team members

Full record on ClinicalTrials.gov

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