Back to resultsImpact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exclusive Enteral Nutrition Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, semen quality, enteral nutrition, CDAI score higher than 150
Eligibility Criteria
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.
Sites / Locations
- Department of General Surgery, Jinling Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Semen quality
Arm Description
Outcomes
Primary Outcome Measures
Sperm motility
Sperm motility is a useful marker of sperm quality. The normal level of sperm motility (World Health Organization criteria) should be higher than 50%.
Secondary Outcome Measures
Crohn's Disease Activity Index
Full Information
NCT ID
NCT02233062
First Posted
September 1, 2014
Last Updated
September 5, 2014
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02233062
Brief Title
Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease
Official Title
Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with crohn's disease.
Detailed Description
The highest age- and sex-adjusted incidence rates for Crohn's Disease (CD) occur during the peak reproductive years. In addition, gastroenterologists frequently advise and manage patients with CD who desire to conceive. Enteral nutrition therapy is effective for induction and maintenance of remission in reproductive age men with CD. However, there is no available data on the effects of enteral nutrition therapy on semen quality. The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with CD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, semen quality, enteral nutrition, CDAI score higher than 150
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Semen quality
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Exclusive Enteral Nutrition Therapy
Primary Outcome Measure Information:
Title
Sperm motility
Description
Sperm motility is a useful marker of sperm quality. The normal level of sperm motility (World Health Organization criteria) should be higher than 50%.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Crohn's Disease Activity Index
Time Frame
Up to 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of General Surgery, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
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Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease
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