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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02233062 |
Date of registration:
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01/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease
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Scientific title:
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Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease |
Date of first enrolment:
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May 2013 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02233062 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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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China
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of Crohn' Disease
- Male patients
- Age: 18-40 years old
- Receive 3-months exclusive enteral nutrition therapy
Exclusion Criteria:
- Used any experimental therapy in the 8 weeks before study entry date
- Had previously documented problems with male reproductive health, such as low sperm
count, impotence, or malignancy
- The use of concomitant medication including sulphasalazine, 5-aminosalicylic acid or
other immune-suppressives.
- Unable to complete the 3-months exclusive enteral nutrition therapy.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Dietary Supplement: Exclusive Enteral Nutrition Therapy
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Primary Outcome(s)
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Sperm motility
[Time Frame: Up to 3 months]
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Secondary Outcome(s)
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Crohn's Disease Activity Index
[Time Frame: Up to 3 months]
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Secondary ID(s)
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NSFC
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20140901
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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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