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Pilot assessment of probiotics for pregnant women in Rwanda.

ABSTRACT: BACKGROUND:While 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 DESIGN:The 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. METHODS:Pregnant 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. RESULTS:The 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. CONCLUSION:Overall 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 REGISTRATION:ClinicalTrials.gov NCT02150655.

SUBMITTER: McMillan A

PROVIDER: S-EPMC6005520 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Pilot assessment of probiotics for pregnant women in Rwanda.

McMillan Amy A Rulisa Stephen S Gloor Gregory B GB Macklaim Jean M JM Sumarah Mark M Reid Gregor G

PloS one 20180618 6

<h4>Background</h4>While 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.<h4>Trial design</h4>The 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 c ...[more]

PMID: 29912913

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Project description:BackgroundMaternal prenatal depressive or anxiety symptoms are associated with adverse maternal and infant health outcomes. With prevalence rates of maternal prenatal depression and anxiety ranging between 10 and 20%, attempts to identify effective interventions to reduce symptoms are priority. There are indications that probiotics can reduce symptoms of maternal depression or anxiety. Probiotics ingested by the mother may thus offer a promising and accessible intervention to complement existing treatments.MethodsThe Probiotics in Pregnancy (PIP) pilot trial is a double-blind, placebo-controlled, randomized pilot trial. While one group orally consumes a probiotic mixture (Ecologic® Barrier; 2,5 × 109 colony forming units/g; 2 g; daily), the other group consumes a placebo, from between 26 and 30 weeks gestation until delivery. Subjects are randomly allocated (1:1) to the intervention or placebo group. Forty healthy pregnant women with symptoms of depression or anxiety and uncomplicated pregnancies at randomization will be included. The primary aim is to determine the feasibility and acceptability of a probiotic trial to reduce symptoms of maternal depression or anxiety in pregnancy. The secondary aim is to exploratorily compare the potential effect of probiotics, compared to placebo, on depressive and/or anxiety symptoms, maternal stress (i.e. reported/hair cortisol), maternal vaginal and intestinal microbiota, and by possibly affecting maternal mood and microbiota, maternal bonding to offspring, infant microbiota and infant crying.DiscussionResults of this pilot trial will help determine whether or not to proceed with a full trial after the pilot trial, and if so, whether revisions should be made to the study protocol and procedures before conducting a full randomized controlled trial. Additionally, they are expected to provide insights into whether changes in psychological, behavioral and biological parameters can be attributed to the probiotic intervention.Trial registrationNetherlands Trial Register, NTR6219 . Registered on 28 February 2017.

Project description:BACKGROUND: Within sub-Saharan Africa, helminth and malaria infections cause considerable morbidity in HIV-positive pregnant women and their offspring. Helminth infections are also associated with a higher risk of mother-to-child HIV transmission. The aim of this study was to determine the prevalence of, and the protective and risk factors for helminth and malaria infections in pregnant HIV-positive Rwandan women receiving anti-retroviral therapy (ART). METHODOLOGY AND PRINCIPLE FINDINGS: Pregnant females (n = 980) were recruited from health centres in rural and peri-urban locations in the central and eastern provinces of Rwanda. Helminth infection was diagnosed using the Kato Katz method whilst the presence of Plasmodium falciparum was identified from blood smears. The prevalence of helminth infections was 34.3%; of malaria 13.3%, and of co-infections 6.6%. Helminth infections were more common in rural (43.1%) than peri-urban (18.0%; p<0.0005) sites. A CD4 count ≤ 350 cells/mm(3) was associated with a higher risk of helminth infections (odds ratio, 3.39; 95% CIs, 2.16-5.33; p<0.0005) and malaria (3.37 [2.11-5.38]; p<0.0005) whilst helminth infection was a risk factor for malaria infection and vice versa. Education and employment reduced the risk of all types of infection whilst hand washing protected against helminth infection (0.29 [0.19-0.46]; p<0.0005);). The TDF-3TC-NVP (3.47 [2.21-5.45]; p<0.0005), D4T-3TC-NVP (2.47 [1.27-4.80]; p<0.05) and AZT-NVP (2.60 [1.33-5.08]; p<0.05) regimens each yielded higher helminth infection rates than the AZT-3TC-NVP regimen. Anti-retroviral therapy had no effect on the risk of malaria. CONCLUSION/SIGNIFICANCE: HIV-positive pregnant women would benefit from the scaling up of de-worming programs alongside health education and hygiene interventions. The differential effect of certain ART combinations (as observed here most strongly with AZT-3TC-NVP) possibly protecting against helminth infection warrants further investigation.

Project description:BACKGROUND:With an aim to prevent adverse pregnancy outcomes, 'birth preparedness and complication readiness' (BP/CR) promotes timely access to skilled maternal and neonatal services. Objective of this study was to assess implementation of BP/CR among pregnant women admitted with obstetric emergencies in rural Rwanda. METHODS:A cross-sectional study among pregnant women who were referred to Ruhengeri hospital between July and November 2015. The 'Safe Motherhood questionnaire' as developed by Jhpiego's Maternal and Neonatal Health Program was used to collect data. Women were asked to mention key danger signs and respond as to whether they had identified: (A) skilled birth attendant, (B) location to give birth, (C) mode of transport, (D) money to cover health care expenditure. Women who answered 'yes' to three or four items were labeled 'well prepared'. Multivariate logistic regression analysis was conducted to compare the 'well prepared' and 'less prepared'. RESULTS:With regard to complication readiness, out of 350 women, 296 (84.6%), 271 (77.4%) and 288 (82.3%) could mention at least one key danger sign during pregnancy, labor and postpartum respectively, but only 23 (6.6%) could mention three or more key danger signs during all three periods. With regard to birth preparedness, 46 (13.1%) women had identified a skilled birth attendant, 68 (19.4%) birth location, 76 (21.7%) mode of transport, and 306 (87.4%) had saved money for health care costs. Seventy-eight women (22.3%) were 'well prepared', associated factors being first time pregnancy (adjusted Odds Ratio (aOR) = 3.2; 95% CI; 1.2-5.8), knowledge of at least two danger signs (aOR = 2.8; 95% CI; 1.7-3.9) and having been assisted by a community health worker at the antenatal clinic (aOR = 2.2, 95% CI; 1.3-3.7). CONCLUSION:Knowledge of obstetric danger signs was suboptimal and birth preparedness low. We recommend review of practices regarding health promotion in antenatal care, taking care not to exclude multiparous women from messages related to birth preparedness, and do promote use of community health workers to enhance effectiveness of BP/CR.

Project description:Exposure to environmental toxins is a 21st century global health problem that is often the result of dietary intake. Although efforts are made to reduce dietary toxin levels, they are often unsuccessful, warranting research into novel methods to reduce host exposure. Food-grade microbes that can be delivered to the gastrointestinal tract and that are capable of sequestering toxins present a safe and cost-effective intervention. We sought to investigate the potential for probiotic-supplemented yogurt to lower heavy metal levels in at-risk populations of pregnant women and in children in Mwanza, Tanzania, and to examine the microbiome in relation to toxin levels. Two populations suspected to have high toxic metal exposures were studied. A group of 44 school-aged children was followed over 25 days, and 60 pregnant women were followed over their last two trimesters until birth. A yogurt containing 10(10) CFU Lactobacillus rhamnosus GR-1 per 250 g was administered, while control groups received either whole milk or no intervention. Changes in blood metal levels were assessed, and the gut microbiomes of the children were profiled by analyzing 16S rRNA sequencing via the Ion Torrent platform. The children and pregnant women in the study were found to have elevated blood levels of lead and mercury compared to age- and sex-matched Canadians. Consumption of probiotic yogurt had a protective effect against further increases in mercury (3.2 nmol/liter; P = 0.035) and arsenic (2.3 nmol/liter; P = 0.011) blood levels in the pregnant women, but this trend was not statistically significant in the children. Elevated blood lead was associated with increases in Succinivibrionaceae and Gammaproteobacteria relative abundance levels in stool. Importance: Probiotic food produced locally represents a nutritious and affordable means for people in some developing countries to counter exposures to toxic metals. Further research and field trials are warranted to explore this approach in countries where communities are located near mining sites and agricultural areas, two types of areas where toxins are likely to be elevated.

Project description:Approximately 3% of all pregnancies are associated with conditions linked with disability, either mild or severe congenital diseases. This is a consequence of environmental and genetic exposures. Complications and poor management of these diseases arise due to limited knowledge, awareness about the disease, and limited resource settings. The current study assessed awareness, attitudes towards genetic diseases, and acceptability of genetic interventions among pregnant women. This was a cross-sectional study that was conducted among 664 pregnant women in six selected health centers in Burera district using a detailed questionnaire. The data were analysed using STATA Version 15 and entailed univariate, bivariate, and multivariable analyses. The level of significance was set at p < 0.05. The mean age of the study participants was 28, and most of them were in the age range of 21 to 30 (50%). Most of the participants were married (91.1%), Christians (98.4%), farmers (92.7%), used public health coverage (96.6%), and attained primary studies (66.1%). The findings from this study showed that among participants, adequate awareness was at 29.5%, inadequate awareness at 70.5%, positive attitudes at 87.1%, negative attitudes at 12.9%, high acceptability at 97.1%, and low acceptability at 2.9%. While there was no significant difference between awareness and acceptability, there was a statistical significance between attitudes towards genetic diseases and acceptability towards the use of genetic services (p < 0.01). There was no statistical significance between sociodemographic or obstetric characteristics and the acceptability of genetic interventions. Participants with positive attitudes towards genetic diseases were more likely to develop a high level of acceptability and willingness towards the use of genetic interventions (OR: 5.3 [2.1-13.5]). Improving awareness about genetic diseases and establishing genetic interventions in healthcare facilities are needed.

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Pilot assessment of probiotics for pregnant women in Rwanda.

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Pilot assessment of probiotics for pregnant women in Rwanda.

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