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Growth, Safety and Efficacy of a Probiotic Supplement

NCT04765852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-03-24

No results posted yet for this study

Summary

The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention

Conditions

  • Probiotic Supplement

Interventions

OTHER

High dose probiotic supplement

One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.

OTHER

Low dose probiotic supplement

One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.

OTHER

Placebo

One placebo stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
21 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2021-08-23
Completion
2021-10-12

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765852 on ClinicalTrials.gov