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

September 5, 2014 updated by: Jianan Ren, Jinling Hospital, China

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Department of General Surgery, Jinling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semen quality
Dietary supplement: Exclusive Enteral Nutrition Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm motility
Time Frame: 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%.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Crohn's Disease Activity Index
Time Frame: Up to 3 months
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140901 (ADDF)
  • NSFC (Other Grant/Funding Number: 81273057)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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