NCT02233062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

September 1, 2014

Last Update Submit

September 5, 2014

Conditions

Crohn's Disease

Keywords

Crohn's Diseasesemen qualityenteral nutritionCDAI score higher than 150

Outcome Measures

Primary Outcomes (1)

  • Sperm motility

    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 Outcomes (1)

  • Crohn's Disease Activity Index

    Up to 3 months

Study Arms (1)

Semen quality

EXPERIMENTAL
Dietary Supplement: Exclusive Enteral Nutrition Therapy

Interventions

Exclusive Enteral Nutrition TherapyDIETARY_SUPPLEMENT
Semen quality

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Crohn' Disease
  • Male patients
  • Age: 18-40 years old
  • Receive 3-months exclusive enteral nutrition therapy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Jinling Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 8, 2014

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

CN(1)