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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37279

Enrollment

Registered

2012-11-19

Start date

2012-10-02

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroenteritis traveller's diarrhea

Interventions

The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks intervention with a milk and whey protein concentrate in healthy volunteers. In this study, the effect of an intervention wit

collection NIZO food research

dose will be 1010 CFU). Before and after infection, an online diary will be kept to record all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also be u

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary study outcomes •Fecal ETEC excretion with time as marker of the colonization resistance •Total daily fecal output as marker of diarrhea	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)