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โ† Trials
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Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan

RecruitingPhase 2Ages 18 Years - 49 YearsFemaleAga Khan University
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In plain words

What the trial is, and whether it could suit you

Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting. Relevance: This trial aims to investigate the concept that a probiotic or live biotherapeutic product, capable of improving gut microbiota composition, can also displace enteropathogens and reduce biomarkers of intestinal inflammation, thereby promoting gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability. Objectives: The primary objective is to

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria * Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \[GA\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent * Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR. * Presence of any of the following WASH conditions - 1. use surface water, unimproved water, or limited water for drinking; OR 2. use surface water, unimproved water, or limited water for cooking; OR 3. use surface water, unimproved water, or limited water for washing utensils; OR 4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR 5. lack facility or have limited facility for handwashing Exclusion criteria Potential participants will not be enrolled if they: * have MUAC โ‰ฅ30 cm * are carrying more than one fetus (i.e., multiple pregnancy) * have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days * have fever or an active infection * 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 anemia as determined using finger stick Hb \< 8 g/dl * have a history of chronic digestive disease * have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder) * have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.) * have known drug hypersensitivity/allergy/intolerance * have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy * are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation * have a plan to observe fast any time during the intervention period * have a plan to leave the study area within the follow-up period * are participating in any other interventional 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.
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What it tests

  • Oral Vancomycin
  • VE818
  • Placebo
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Where

1 site
Mother and Child Health Research and Training Center, AKU
Matiari, Pakistan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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