Efficacy of a Dietary Supplement in Infants

NCT07341477 | Not Yet Recruiting

• 1 other identifier: 2406INF
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Infants

Keywords

Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• Probiotic abundance

  Fecal probiotic abundance

  At 5 months (V4) of intervention

Secondary Outcomes (18)

• Fecal metabolic biomarker

  At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.

• Growth parameter: Weight

  At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention.

• Growth parameter: Length

  At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.

• Growth parameter: Head circumference

  At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.

• GI-related Behavior: Infant Gastrointestinal Symptom Questionnaire (IGSQ)

  At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

Dietary Supplement: Experimental Group

Control Group (CG)

PLACEBO COMPARATOR

Other: Control Group (CG)

Interventions

Experimental Group DIETARY_SUPPLEMENT

Dietary supplement in powder form

Experimental Group (EG)

Control Group (CG) OTHER

Placebo dietary supplement in powder form

Control Group (CG)

Eligibility Criteria

• Age: 19 Weeks - 21 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dr. Mitzi Trinidad-Aseron

  University of Perpetual Help Dalta Medical Center, Philippines

  PRINCIPAL INVESTIGATOR

• Dr. Maria Josefa Nantes

  Silang Specialists Medical Center, Philippines

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renette Foo

CONTACT

+6568905709; shufenrenette.foo@rd.nestle.com

Marie-Annick Hauser

CONTACT

+41317901625; Marie-Annick.Hauser@rd.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unique (individual) coding of the study products
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled nutritional study.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share