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Completed

NCT Number: NCT02233062

Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of 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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of General Surgery, Jinling Hospital

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exclusive Enteral Nutrition Therapy

Dietary Supplement

Primary outcomes

  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 outcomes

  1. Crohn's Disease Activity Index

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 8, 2014
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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