Health TrialsbyHealthPanel

Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements

ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-28
SponsorSociété des Produits Nestlé (SPN)

About this trial

This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age

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

Disqualifiers

Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol

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)

Previous or ongoing antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotic dietary supplement

    Dietary supplement

    Probiotic dietary supplement administered once per day

  • Placebo dietary supplement

    Dietary supplement

    Placebo dietary supplement administered once per day

Treatment groups

327 Participants
are divided into 3 treatment groups
Group A: EG1 SupplementExperimental treatment 1 intervention
Group B: EG2 SupplementExperimental treatment 1 intervention
Group C: CG supplementPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weight gain velocity

Weight gain velocity (g/day)

Time frame
From baseline (V1) to 2.5 months (V3)

Secondary outcomes

1

Growth Measure: Weight

Weight in grams and corresponding weight-for-age Z-scores according to World Health Organization (WHO) child growth standards

Time frame
At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
2

Growth Measure: Length

Length in centimeters and corresponding length-for-age Z-scores according to WHO child growth standards

Time frame
At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
3

Growth Measure: Head circumference

Head circumference in centimeters and corresponding head circumference-for-age Z-scores according to WHO child growth standards

Time frame
At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
4

Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Gastrointestinal Symptom Questionnaire (IGSQ)

The IGSQ is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fussiness, and flatulence. The total score can range from 13-65 with lower scores indicating lower gastrointestinal symptom burden.

Time frame
At baseline (V1), 1.5 months (V2), and 2.5 months (V3)

Other outcomes

Sponsors and contacts

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

Société des Produits Nestlé (SPN)

Lead sponsor

University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines

Collaborator

Asian Hospital and Medical Center, Muntinlupa, Philippines

Collaborator

Source ClinicalTrials.gov
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