Ability of the probiotic VE-818 to reduce enteropathogen colonization and improve environmental enteropathy in pregnant women: a proof of concept and phase II randomized placebo-controlled trial

TROPGA0 个研究点目标入组 144 人开始时间: 2023年11月13日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Women aged 18 years or older in the first or early second trimester of pregnancy, living in defined ge-ographical areas of Chawama, Misi and Kuku compounds where, based on previous studies, it can be assumed that environmental enteropathy is prevalent.
•EMP Pregnancy 2 Trial Protocol Version 0.1, 30th October 2023 Page 22 of 50
•Presence of any 2 bacterial pathogens from the list of selected bacterial enteropathogens (non-ty-phoid salmonellae, Shigella spp/enteroinvasive EIEC, Campylobacter spp, ETEC, EPEC, EAEC, EHEC, Aer-omonas spp, Plesiomonas spp, Vibrio cholerae,) in the stool sample detected by TAC (qPCR).

•Potential participants will not be enrolled if they:
•have had diarrhoea, 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 any illness which in the opinion of the investigator will complicate the assessment of safety or efficacy
•? have severe anemia as determined using finger stick hemoglobin and Hgb < 8 g/dl.(Ref: WHO/UNICEF/UNU, Iron Deficiency Anaemia Assessment, Prevention, and Control: A Guide for Programme Managers,” Geneva, 2001)
•have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder.)
•have any contra-indication to the use of vancomycin
•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
•inclusion in any other interventional trial but may be enrolled if/when these disqualifiers have expired.

发起方

TROPGA