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

NCT ID: NCT02233062

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Semen quality

Group Type EXPERIMENTAL

Exclusive Enteral Nutrition Therapy

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Exclusive Enteral Nutrition Therapy

Intervention Type DIETARY_SUPPLEMENT

Eligibility 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Jianan Ren

Vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of General Surgery, Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NSFC

Identifier Type: OTHER

Identifier Source: secondary_id

20140901

Identifier Type: -

Identifier Source: org_study_id

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