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NCT02233062 Clinical Trial

Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02233062
Other study ID # 20140901
Secondary ID NSFC
Status Completed
Phase N/A
First received September 1, 2014
Last updated September 5, 2014
Start date May 2013
Est. completion date August 2014

Study information
Verified date September 2014
Source Jinling Hospital, China
Contact n/a
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with crohn's disease.

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Exclusive Enteral Nutrition Therapy

Locations
Country Name City State
China Department of General Surgery, Jinling Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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%. Up to 3 months No
Secondary Crohn's Disease Activity Index Up to 3 months No
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