Crohn's DiseaseNCT02233062
Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease
A study testing Exclusive Enteral Nutrition Therapy in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Exclusive Enteral Nutrition Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Crohn' Disease
- Male patients
- Age: 18-40 years old
- Receive 3-months exclusive enteral nutrition therapy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Jinling Hospital
Nanjing, Jiangsu, 210000
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Exclusive Enteral Nutrition Therapy
- Keywords
- Crohn's Disease, semen quality, enteral nutrition, CDAI score higher than 150
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive Enteral Nutrition TherapyDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Semen quality | Experimental | Not described Receives: Dietary Supplement: Exclusive Enteral Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Up to 3 months
Secondary outcomes (1)
Crohn's Disease Activity Index
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Ren, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233062
- Sponsor's protocol ID
- 20140901
- Other IDs
- NSFC
- Status last verified
- Sep 2014
- First submitted
- 1 Sep 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02233062
- Acronym / sponsor ID
- 20140901
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, semen quality, enteral nutrition, CDAI score higher than 150
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with crohn's disease.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semen quality | Experimental | Dietary Supplement: Exclusive Enteral Nutrition Therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Crohn' Disease
- Male patients
- Age: 18-40 years old
- Receive 3-months exclusive enteral nutrition therapy
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exclusive Enteral Nutrition Therapy | Dietary supplement | Semen quality |
Primary outcome
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%.
1 secondary outcome
Crohn's Disease Activity Index
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exclusive Enteral Nutrition Therapy in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm motility (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.