NCT04685252

Investigating a Probiotic on Mothers' Mood and Stress

Completed NA Last updated 24 March 2023

What this trial tests

NA trial testing (BL) NCC3001 in Perinatal Problems in 184 participants. Completed in 20 May 2022.

Timeline

6 November 2020

Primary endpoint
24 February 2022

20 May 2022

Quick facts

Lead sponsor	Société des Produits Nestlé (SPN)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	184
Start date	6 November 2020
Primary completion	24 February 2022
Estimated completion	20 May 2022
Sites	1 location across Singapore

Drugs / interventions tested

• (BL) NCC3001
• Placebo

Conditions studied

• Perinatal Problems — all drugs for Perinatal Problems →
• Mood Change — all drugs for Mood Change →
• Stress-related Problem — all drugs for Stress-related Problem →

Sponsor

Société des Produits Nestlé (SPN) — full company profile →

Who can join

21 and older, female only, with Perinatal Problems or Mood Change. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Does the Gut Microbial Metabolome Really Matter? The Connection between GUT Metabolome and Neurological Disorders.
   Marć MA, Jastrząb R, Mytych J. · · 2022 · cited 18× · PMID 36235622 · DOI 10.3390/nu14193967
2. A Probiotic Intervention With Bifidobacterium longum NCC3001 on Perinatal Mood Outcomes (PROMOTE Study): Protocol for a Decentralized Randomized Controlled Trial.
   Toh MPS, Yang CY, Lim PC, Loh HLJ, et al · · 2023 · cited 5× · PMID 37018024 · DOI 10.2196/41751
3. The impact of ingestion of Bifidobacterium longum NCC3001 on perinatal anxiety and depressive symptoms: a randomized controlled trial.
   Fries LR, Boehme M, Lavalle L, Sakwinska O, et al · · 2025 · cited 3× · PMID 40175540 · DOI 10.1038/s41598-025-95651-1
4. Decentralized clinical trials are better for the participants and for the planet: the case study of a double-blind randomized controlled trial in Singapore (PROMOTE study).
   Fries LR, Khaled N, Viveros Santos I, Suniega-Tolentino E, et al · · 2024 · cited 2× · PMID 39872102 · DOI 10.3389/fpubh.2024.1508166