Milk Ingredients and Resistance Against E-coli-induced GastroEnteritis (MIRAGE) (MIRAGE)
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|ClinicalTrials.gov Identifier: NCT01800396|
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : August 27, 2015
Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year. Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of infections. One of the possibilities is to strengthen human resistance to gut infections by consumption of milk ingredients.
Aim: To study whether a milk protein concentrate rich in phospholipids improves the resistance of humans to enterotoxigenic E. coli (ETEC).
Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks intervention with a milk protein concentrate rich in phospholipids in healthy subjects of 18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate rich in phospholipids or placebo group (n=30 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; 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 used for daily recording of bowel habits and frequency and severity of gastrointestinal complaints.
The following biological samples will be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and the fecal samples are collected to quantify several infection- and immune system markers and to verify dietary calcium intake. Saliva is sampled three times before and after infection to quantify immune system markers.
Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day).
Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative fecal wet weight.
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infection Diarrhea Gastroenteritis||Dietary Supplement: Milk protein Dietary Supplement: Milk protein rich in phospholipids||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-controlled, Double Blind Volunteer Study Into the Effect of Milk Ingredients on Gastroenteritis Caused by an Attenuated E.Coli.|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Placebo Comparator: Milk protein
Milk powder, twice daily at breakfast and dinner.
Dietary Supplement: Milk protein
Experimental: Milk protein rich in phospholipids
Milk powder, twice daily at breakfast and dinner.
Dietary Supplement: Milk protein rich in phospholipids
- Change of fecal ETEC numbers over time as a marker of intestinal colonization resistance [ Time Frame: Days -1 and -2 before ETEC challenge and days 1,2,3,4,7 and 15 after challenge ]The change over time in fecal ETEC numbers is compared between treatment and placebo group.
- Change of total daily fecal output over time as a marker of infectious diarrhea [ Time Frame: Days -1 and -2 before ETEC challenge and on days 1,2,3,4,7 and 15 after challenge. ]The change in the daily fecal output over time is compared between treatment and placebo group.
- Daily Bristol Stool Score as a marker for stool consistency [ Time Frame: Days -1 and -2 before ETEC challenge and on days 1-15 after challenge. ]
- Gastro-Intestinal Symptom Rating Scale (GSRS) for gastro-intestinal complaints [ Time Frame: Days -1 and -2 before ETEC challenge and on days 1-15 after challenge ]
- % fecal wet weight as a marker for Diarrhea severity [ Time Frame: Days -1 and -2 before ETEC challenge and days 1-15 after challenge. ]
- Stool frequency (number of stools per day) [ Time Frame: Day -1 and -2 and days 0-15 ]Days -1 and -2 before ETEC challenge and on days 1-15 after challenge
- Specific serum antibody response to CFAII [ Time Frame: Before ETEC challenge and on day 15 after challenge. ]
- Calprotectin in feces [ Time Frame: Before ETEC challenge and on day 2 and 3 after challenge. ]
- Total fecal and salivary sIgA [ Time Frame: Before ETEC challenge and on day 3 and 4 after challenge. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800396
|NIZO food research|
|Ede, Netherlands, 6718ZB|
|Principal Investigator:||Sandra Ten Bruggencate, PhD||NIZO food research, The Netherlands|