SEARCHRCTobstetrics and gynecology, psychiatry

RCT·obstetrics and gynecology, psychiatry, clinical nutrition, pediatrics, clinical trial·PMC10131660

A Probiotic Intervention With Bifidobacterium longum NCC3001 on Perinatal Mood Outcomes (PROMOTE Study): Protocol for a Decentralized Randomized Controlled Trial

JMIR Research Protocols · 12 authors, 5 centres

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TL;DR

This is a protocol for a decentralized, randomized controlled trial testing whether the probiotic Bifidobacterium longum NCC3001, taken during pregnancy and/or postpartum, can reduce symptoms of depression, anxiety, and stress in perinatal women.

Full summary

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The PROMOTE study is a decentralized randomized controlled trial protocol designed to test the efficacy of probiotic Bifidobacterium longum NCC3001 for perinatal mood symptoms. The central result reported is the successful recruitment and high retention (179 completers) of a vulnerable population during the COVID-19 pandemic, using digital tools. However, this is a protocol paper; no efficacy data or conclusions about the probiotic's effect on mood outcomes are provided.

STUDY TYPE

RCT

SPECIALTY

obstetrics and gynecology

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AI pipeline

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100% · A

ORIGINAL PAPER

PMC10131660

A Probiotic Intervention With Bifidobacterium longum NCC3001 on Perinatal Mood Outcomes (PROMOTE Study): Protocol for a Decentralized Randomized Controlled Trial

JMIR Research Protocols

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ABSTRACT

Background Perinatal mood disorders such as depression and anxiety are common, with subclinical symptomology manifesting as perinatal mood disturbances being even more prevalent. These could potentially affect breastfeeding practices and infant development. Pregnant and lactating women usually limit their exposure to medications, including those for psychological symptoms. Interestingly, the naturally occurring probiotic Bifidobacterium longum (BL) NCC3001 has been shown to reduce anxious behavior in preclinical models and feelings of low mood in nonpregnant human adults. During the COVID-19 pandemic, mental health issues increased, and conventionally conducted clinical trials were restricted by social distancing regulations. Objective This study, Probiotics on Mothers’ Mood and Stress (PROMOTE), aimed to use a decentralized clinical trial design to test whether BL NCC3001 can reduce symptoms of depression, anxiety, and stress over the perinatal period. Methods This double-blind, placebo-controlled, randomized, and 3-parallel-arm study aimed to recruit 180 women to evaluate the efficacy of the probiotic taken either during pregnancy and post partum (from 28-32 weeks’ gestation until 12 weeks after delivery; n=60, 33.3%) or post partum only (from birth until 12 weeks after delivery; n=60, 33.3%) in comparison with a placebo control group (n=60, 33.3%). Participants consumed the probiotic or matched placebo in a drink once daily. Mood outcomes were measured using the State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale questionnaires, captured electronically at baseline (28-32 weeks’ gestation) and during e-study sessions over 5 further time points (36 weeks’ gestation; 9 days post partum; and 4, 8, and 12 weeks post partum). Saliva and stool samples were collected longitudinally at home to provide mechanistic insights. Results In total, 520 women registered their interest on our website, of whom 184 (35.4%) were eligible and randomized. Of these 184 participants, 5 (2.7%) withdrew after randomization, leaving 179 (97.3%) who completed the study. Recruitment occurred between November 7, 2020, and August 20, 2021. Advertising on social media brought in 46.9% (244/520) of the prospective participants, followed by parenting-specific websites (116/520, 22.3%). Nationwide recruitment was achieved. Data processing is ongoing, and there are no outcomes to report yet. Conclusions Multiple converging factors contributed to speedy recruitment and retention of participants despite COVID-19–related restrictions. This decentralized trial design sets a precedent for similar studies, in addition to potentially providing novel evidence on the impact of BL NCC3001 on symptoms of perinatal mood disturbances. This study was ideal for remote conduct: because of the high digital literacy and public trust in digital security in Singapore, the intervention could be self-administered without regular clinical monitoring, and the eligibility criteria and outcomes were measured using electronic questionnaires and self-collected biological samples. This design was particularly suited for a group considered vulnerable—pregnant women—during the challenging times of COVID-19–related social restrictions. Trial Registration ClinicalTrials.gov NCT04685252 ; https://clinicaltrials.gov/ct2/show/ NCT04685252 International Registered Report Identifier (IRRID) DERR1-10.2196/41751

CITATION EXPORT

Melissa P S Toh, Chui Yuen Yang, Phei Cze Lim et al.. A Probiotic Intervention With Bifidobacterium longum NCC3001 on Perinatal Mood Outcomes (PROMOTE Study): Protocol for a Decentralized Randomized Controlled Trial. JMIR Research Protocols. (2023). https://doi.org/10.2196/41751

AUTHORS

12 · 5 CENTRES

Melissa P S Toh, Chui Yuen Yang, Phei Cze Lim, Hui Li J Loh, Gabriela Bergonzelli, Luca Lavalle, Elias Mardhy, Tinu Mary Samuel, Elvira Suniega-Tolentino, Irma Silva Zolezzi, Lisa R Fries, Shiao Yng Chan

1 Singapore Institute for Clinical Sciences Agency for Science, Technology and Research Singapore Singapore
2 Nestle Research, Lausanne Lausanne Switzerland
3 Nestle Research, Singapore Singapore Singapore
4 Nestle Research, Beijing Beijing China
5 Department of Obstetrics and Gynaecology Yong Loo Lin School of Medicine National University of Singapore Singapore Singapore

EDITOR / REVIEWER

Amaryllis Mavragani, Mansour Almanaa