Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial

Institut Pasteur Dakar0 个研究点目标入组 76 人开始时间: 2023年10月22日最近更新: 2024年3月4日

试验速览

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•Any pregnant woman in the second trimester of pregnancy (confirmed by ultrasound)
•Adult (18 years old)
•living in defined geographical areas of Guediawaye
•Full understanding and consent agreement to participate in protocol as planned

•Had diarrhea, defined as the release of three or more loose stools per 24 hours in the previous 14 days.
•Have taken antibiotics or probiotics in the previous 14 days
•Have taken non-steroidal anti-inflammatory drugs or corticosteroids in the previous 14 days
•Have hemoglobin <8g/dl
•Have multiple pregnancies
•Have a disease that, in the investigator’s opinion, would complicate the assessment of safety or efficacy.
•Have a gastrointestinal contraindication to ingesting a capsule (known or suspected gastrointestinal obstruction, stenosis, fistula, gastroparesis or any swallowing disorder).
•Have plans to leave Guédiawaye during the follow-up period
•Included in any other interventional trial
•However, they may be included in the trial when these criteria have expired.

发起方

Institut Pasteur Dakar