Environmental Enteric Dysfunction Clinical Trial
— MPIGHOfficial title:
Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia
This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale trials in which birth outcomes and postnatal growth will be key endpoints.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women aged 18 years or older in the first trimester or early second trimester of pregnancy, living in defined geographical areas of Bangladesh (Matlab), Pakistan, Senegal and Zambia, where it can be assumed that environmental enteropathy is universal Exclusion Criteria: - Potential participants will not be enrolled if they: - have had diarrhea, defined as the passage of three or more loose stools per 24 hours, in the preceding 14 days - have taken antibiotics or probiotics in the preceding 14 days - have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days - have severe pallor (hemoglobin concentration <8g/dl) - have any chronic disease, illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy - have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder) - have the plan to observe fast at any time during the intervention period - have the plan to leave the study area within the follow-up period - are included in any other intervention trial - belong to a household from which another woman is already enrolled in the study but may be enrolled if/when these disqualifiers have expired |
Country | Name | City | State |
---|---|---|---|
Bangladesh | International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) | Chandpur |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | Bill and Melinda Gates Foundation |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Recovery of useful data from CapScan | Completion of whole gut microbiome profiles | 56 days | |
Other | Diversity, centroids and distributions of microbial taxa from sequenced CapScan samples | microbial taxa of stool Analyzing samples from the same study population | 56 days | |
Other | Fetal growth | Using serial pregnancy ultrasound | 6 months | |
Other | Stillbirth | Death or loss of a baby before or during delivery | At birth | |
Other | Neonatal death | Death of a child within 28 days after birth | From birith to 28 days after birth | |
Other | Preterm birth | Babies born alive before 37 weeks of pregnancy are completed | At birth | |
Other | Apgar score | A measure of the physical condition of a newborn infant (0-10) | At birth | |
Other | Birth weight | Infant weight at birth in grams | At birth/7 days within birth | |
Other | Birth length | Infant length at birth in cm | At birth/7 days within birth | |
Other | Birth head circumference | Infant head circumference at birth in cm | At birth/7 days within birth | |
Other | Low birth weight | birth weight less than 2500 g | At birth/7 days within birth | |
Other | Small for gestational age | Birth weight of less than 10th percentile for gestational age | At birth/7 days within birth | |
Other | Women's mental health | By follow ups | 2 years | |
Other | Women's postpartum weight loss/retention | Follow ups | 1 year | |
Other | Infant weight | Infant weight in grams | 1 year | |
Other | Infant length | Infant length in cm | 1 year | |
Other | Infant morbidity | Number of episodes of any morbidity | 1 year | |
Primary | Percentage change (mean, unweighted) in a multiple panel of biomarkers between baseline and last sample collected after 56 days of treatment, compared to control group | Plasma CRP, AGP, sCD14, LBP, CD163, iFABP, and fecal myeloperoxidase, neopterin, calprotectin and lipocalin by ELISA | 56 days | |
Secondary | Reduction in colonisation | Specific enteropathogens (Salmonella, Shigella, Campylobacter, ETEC, EPEC, EAEC, rotavirus, norovirus, Giardia and Cryptosporidium) by TaqMan Array cards, between baseline and last sample collected after 56 days of treatment, in Vivomixx compared to placebo groups | 56 days | |
Secondary | Change in microbiome | Measured by whole-genome shotgun metagenomic sequencing, post versus pre intervention, in the intervention and placebo groups | 56 days | |
Secondary | Change in untargeted metabolome | Measured by LC-MS/MS in fecal and CapScan samples | 56 days | |
Secondary | Reduction in intestinal permeability | Measured by lactulose-rhamnose (LR) ratio in Vivomixx compared to placebo group | 56 days | |
Secondary | Change in weight gain velocity in the 2nd trimester of pregnancy | Rate of weight gain (kg/week) | 14 weeks |
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