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

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ClinicalTrials.gov Identifier: NCT02233062
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Jianan Ren, 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: Exclusive Enteral Nutrition Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease
Study Start Date : May 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semen quality Dietary Supplement: Exclusive Enteral Nutrition Therapy



Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. Crohn's Disease Activity Index [ Time Frame: Up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233062


Locations
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China, Jiangsu
Department of General Surgery, Jinling Hospital
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Jinling Hospital, China

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Responsible Party: Jianan Ren, Vice president, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02233062     History of Changes
Other Study ID Numbers: 20140901
NSFC ( Other Identifier: National Natural Science Foundation of China )
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014

Keywords provided by Jianan Ren, Jinling Hospital, China:
Crohn's Disease
semen quality
enteral nutrition
CDAI score higher than 150

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases