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

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Dietary Supplement: Exclusive Enteral Nutrition Therapy

• Registration Number: NCT02233062
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-05
• Last Update Submitted: 2014-09-05
• Study First Posted: 2014-09-08
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Semen quality	Exclusive Enteral Nutrition Therapy	-

Primary Outcome Measures

Name	Time	Method
Sperm motility	Up to 3 months	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

Name	Time	Method
Crohn's Disease Activity Index	Up to 3 months

Trial Locations

Locations (1)

Department of General Surgery, Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China