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

J

Jinling Hospital, China

Status

Completed

Conditions

Crohn's Disease

Treatments

Dietary Supplement: Exclusive Enteral Nutrition Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02233062
NSFC (Other Identifier)
20140901

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Semen quality
Experimental group
Treatment:
Dietary Supplement: Exclusive Enteral Nutrition Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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