Health TrialsbyHealthPanel

Efficacy of a Dietary Supplement in Infants

ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-21
SponsorSociété des Produits Nestlé (SPN)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental Group

    Dietary supplement

    Dietary supplement in powder form

  • Control Group (CG)

    Other intervention

    Placebo dietary supplement in powder form

Treatment groups

172 Participants
are divided into 2 treatment groups
Group A: Experimental Group (EG)Experimental treatment 1 intervention
Group B: Control Group (CG)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Probiotic abundance

Fecal probiotic abundance

Time frame
At 5 months (V4) of intervention

Secondary outcomes

1

Fecal metabolic biomarker

To assess changes in key fecal metabolic biomarkers such as fecal water-soluble vitamins, fecal organic acids, and other fecal metabolites.

Time frame
At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.
2

Growth parameter: Weight

Weight in grams and corresponding weight-for-age Z-score according to WHO growth standards

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

Growth parameter: Length

Length in cm and corresponding weight-for-age Z-score according to WHO growth standards

Time frame
At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.
4

Growth parameter: Head circumference

Head circumference in cm and corresponding head circumference-for-age Z-score according to WHO growth standards

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Société des Produits Nestlé (SPN)

Lead sponsor

Source ClinicalTrials.gov
Apply now