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Trial record 21 of 181 for:    Phospholipids

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
Sponsor:
Collaborators:
Arla Foods
Denmark
Information provided by (Responsible Party):
NIZO Food Research

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. 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 ]
  3. % fecal wet weight as a marker for Diarrhea severity [ Time Frame: Days -1 and -2 before ETEC challenge and days 1-15 after challenge. ]
  4. 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

  5. Specific serum antibody response to CFAII [ Time Frame: Before ETEC challenge and on day 15 after challenge. ]

Other Outcome Measures:
  1. Calprotectin in feces [ Time Frame: Before ETEC challenge and on day 2 and 3 after challenge. ]
  2. Total fecal and salivary sIgA [ Time Frame: Before ETEC challenge and on day 3 and 4 after challenge. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age 18-55 yrs
  • 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 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, liver, bile bladder, kidney, thyroid gland (self-reported)
  • 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 agents (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)
  • ETEC detected in fecal sample (collected at screening)
  • Vegetarians
  • Vegans
  • Heavy alcohol use (>4 consumptions/day or >20/week)
  • Drug use

Information from the National Library of Medicine

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


Locations
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Netherlands
NIZO food research
Ede, Netherlands, 6718ZB
Sponsors and Collaborators
NIZO Food Research
Arla Foods
Denmark
Investigators
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Principal Investigator: Sandra Ten Bruggencate, PhD NIZO food research, The Netherlands

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NIZO Food Research
ClinicalTrials.gov Identifier: NCT01800396     History of Changes
Other Study ID Numbers: NL41768.081.12
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by NIZO Food Research:
Bacterial infection
Dairy
Diarrhea
Diet
E.Coli
Gastroenteritis
Milk
Stool consistency
Additional relevant MeSH terms:
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Bacterial Infections
Gastroenteritis
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action