A randomized, placebo-controlled, double blind volunteer study into the effect of milk ingredients on gastroenteritis caused by an attenuated E. coli.

Completed

Conditions: gastroenteritis
traveller's diarrhea
10017966
10004018

Registration Number: NL-OMON37279

Lead Sponsor: Arla Foods Ingredients Group P/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Healthy male subjects, aged 18-55 yrs, living in the Ede/Wageningen neighbourhood - Informed consent -Availability of internet connection - Willingness to replace habitual dairy product intake with the supplied lowcalcium 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.

Exclusion Criteria

Current or previous underlying disease of the GI tract - Allergy to milk products or lactose intolerance (selfreported)- 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 - Vegans - Heavy alcohol use (>4 consumptions/day or >20/week) -Drug use

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study outcomes<br /><br>•Fecal ETEC excretion with time as marker of the colonization resistance<br /><br>•Total daily fecal output as marker of diarrhea</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study outcomes<br /><br>•Bowel habits<br /><br>•Frequency and severity of gastrointestinal symptoms<br /><br>•Diarrhea severity (as measured by fecal dry weight excretion and % fecal dry<br /><br>weight)<br /><br>•Specific serum antibody response to CFA-II<br /><br><br /><br>Tertiary study outcomes<br /><br>•Opportunistic pathogens in feces<br /><br>•Calprotectin in feces<br /><br>•Total faecal and salivary sIgA<br /><br>The performance of analyses of tertiary study outcomes will depend on the<br /><br>results of the primary and secondary study outcomes. </p><br>