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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01335503 |
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Date of registration:
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12/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of AN-PEP Enzyme on Gluten Digestion
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Scientific title:
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Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01335503 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Ad Masclee, Prof Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastricht University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male/female
- Age = 18 years but < 45 years
- Hormonal contraceptive treatment
- Subject has read and understood the information provided on the study and given
written informed consent
Exclusion Criteria:
- Any medical condition or laboratory test result that in the opinion of the
investigators may interfere with the study and may jeopardise the health status of
the participant
- pregnancy or lactation
- women not treated with hormonal contraceptive treatment
Age minimum:
18 Years
Age maximum:
44 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gluten Digestion
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Intervention(s)
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Dietary Supplement: AN-PEP
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Primary Outcome(s)
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Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum
[Time Frame: 0-240 min]
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Secondary Outcome(s)
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Effect of AN-PEP and meal caloric density on gastric and duodenal pH
[Time Frame: 0-240 min]
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Effect of meal caloric density on gastric emptying
[Time Frame: 0-240 min]
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Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach
[Time Frame: 0-240 min]
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Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum
[Time Frame: 0-240 min]
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Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach
[Time Frame: 0-240 min]
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Secondary ID(s)
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AN-PEP-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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