Evidence map›Paper›PMID 29912913›Full record

Trial reportPloS one2018

Pilot assessment of probiotics for pregnant women in Rwanda.

Amy McMillan, Stephen Rulisa, Gregory B Gloor, Jean M Macklaim, Mark Sumarah, Gregor Reid

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02150655 (Pilot Study Investigating Bacteria), which is not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
4.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02150655 early_phase1completednot on this map

Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women.

TypeinterventionalSponsorWestern University, CanadaRan2012 to 2013Enrolled30ConditionsVulvovaginal Candidiasis, Bacterial VaginosisArmsLactobacillus GR-1 and Lactobacillus RC-14 oral capsules, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

Amy McMillanCentre for Human Microbiome and Probiotics, Lawson Health Research Institute, London, Canada.
Stephen RulisaDepartment of Obstetrics and Gynecology, University of Rwanda, Kigali, Rwanda.
Gregory B GloorCentre for Human Microbiome and Probiotics, Lawson Health Research Institute, London, Canada.
Jean M MacklaimCentre for Human Microbiome and Probiotics, Lawson Health Research Institute, London, Canada.
Mark SumarahAgriculture and Agri-Food Canada, London, Canada.
Gregor ReidCentre for Human Microbiome and Probiotics, Lawson Health Research Institute, London, Canada.ORCID 0000-0001-9658-5696
Western University · CAAgriculture and Agri-Food Canada · CALawson Health Research Institute · CAUniversity of Rwanda · RW

Funding

Canadian Institute Health Research 227328
6 · The paper itself

Abstract

backgroundWhile the global market for probiotics is soon to reach in excess of US$50 billion, the continent of Africa has been largely ignored, despite these products having the ability to reduce the burden of disease and death. TRIAL

designThe present randomised, blinded, placebo-controlled clinical trial was undertaken in Rwanda, a country devoid of well-documented probiotics. The primary outcome aim was to examine receptivity and compliance for orally administered probiotic capsules containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 in pregnant women and assess any initial side effects or changes to the vaginal microbiome.

methodsPregnant women between the ages of 18 and 55 were recruited from the Nyamata District Hospital in Rwanda and randomly assigned to receive probiotic or placebo capsules for one month. Clinicians were blinded to the treatments.

resultsThe drop-out rate was 21%, with 13 of 18 women in the placebo group and 17 of 20 in the probiotic group completing the study. Only 13 women returned for birthing and additional sample collection. No side effects of either treatment group were reported. Microbiota and metabolomics data showed similar findings to those reported in the literature, with low bacterial diversity and Lactobacillus dominance associated with a healthy vagina, and birthing associated with high diversity. Despite the small sample size and lack of changes in the microbiota, women in the placebo arm were significantly more likely to give birth pre-term.

conclusionOverall women were receptive to the probiotic concept, but the lack of information on such products and logistical and economical challenges pose problems for wider population engagement.

trial registrationClinicalTrials.gov NCT02150655.

Indexed as

Lacticaseibacillus rhamnosusMicrobiotaAdolescentAdultFemaleHumansMiddle AgedPilot ProjectsPregnancyProbioticsRwandaVagina

Identifiers

PMID29912913
PMCPMC6005520
OpenAlexW2809477798

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.