Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals
NCT ID: NCT02060864
Last Updated: 2015-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2014-04-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Placebo
2 Placebo pills
Placebo
AN-PEP 80.000 PPI
1 pill AN-PEP 80.000 PPI and 1 pill Placebo.
AN-PEP
Two pills are consumed in the morning with a breakfast
AN-PEP 160.000 PPI
2 pills AN-PEP 80.000 PPI
AN-PEP
Two pills are consumed in the morning with a breakfast
Interventions
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AN-PEP
Two pills are consumed in the morning with a breakfast
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 but \<70 yr
* Females: Hormonal contraceptive treatment
* Self-reported gluten-sensitive individuals fulfilling the Rome III criteria while consuming gluten
* Subject has read and understood the information provided on the study and given written informed consent
Exclusion Criteria
* Wheat allergy (serological test for wheat protein IgE antibodies)
* Medication or medical condition that affects gastric emptying or secretion
* Females: Pregnancy or breast-feeding
* Inability to swallow the gastroduodenal feeding tube
* Any medical condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
* Any condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
18 Years
69 Years
ALL
Yes
Sponsors
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DSM Food Specialties
INDUSTRY
Responsible Party
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Robert Brummer
Prof
Locations
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Örebro University
Örebro, , Sweden
Countries
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Other Identifiers
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AN-PEP-03
Identifier Type: -
Identifier Source: org_study_id
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