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Investigating a Probiotic on Mothers' Mood and Stress

NCT04685252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2023-03-24

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, double-blind, 3 parallel-arm study in pregnant women aged 21 years old and above. The study aims to assess changes in perinatal mood and stress when administering a probiotic starting from either the 3rd trimester (i.e 28-32 weeks of gestational age) or immediately after birth, until 12 weeks post-partum.

Conditions

  • Perinatal Problems
  • Mood Change
  • Stress-related Problem

Interventions

OTHER

(BL) NCC3001

Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.

OTHER

Placebo

Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Lisa Fries, PhD. · NESTLE RESEARCH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2022-02-24
Completion
2022-05-20

Countries

  • Singapore

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 NCT04685252 on ClinicalTrials.gov