A randomized, placebo-controlled, double blind human trial into the effect of Protecflor on gastroenteritis caused by attenuated E. Coli - PROTETEC

allemand Human Nutrition0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Healthy male subjects, aged 20-55 yrs, living in the Ede/Wageningen neighbourhood
•- Informed consent
•- Availability of internet connection
•- Willingness to replace habitual dairy product intake with the supplied low-calcium soy products
•- Willingness to abstain from products with high amounts of prebiotic fibers and from products with probiotics (except for the supplied one) starting 1 month prior to study start
•- Willingness to give up blood donation from 1 month before the start of the experiment and during the entire experimental period.

•- Current or previous underlying disease of the GI tract
•- Allergy to milk products or lactose intolerance (self-reported), since the capsules may contain milk traces from culture media
•- Allergy to soy products (self-reported)
•- Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion).
•- High titer serum antibodies against ETEC (10 ml blood sample collected at screening).
•- Vegetarians
•- Heavy alcohol use (>4 consumptions/day or >20/week)
•- Drug use

发起方

allemand Human Nutrition