Crohn's DiseaseNCT01823042
The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)
A study testing azathioprine+enteral nutrition and Azathioprine in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
Trial summary
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- azathioprine+enteral nutrition and Azathioprine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Jul 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
- Lesions located in ileum or ileocecal region
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Body weight between 40 and 100 kg, inclusive.
- Subjects should have a CDAI score <150 at week 0
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- Able to swallow tablets
- Are capable of providing written informed consent and obtained at the time of enrollment
- Willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Bacterial,viral or other microbial infection(including HIV)
- any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs
- any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab.
- current use of prescription doses or chronic/frequent use of NSAIDs
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- Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted, providing that the dose is not increased during the study period.)
- History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
- WBC <3.0 x 109/L, hemoglobin <80 g/L, Platelets<50,000/mm3 at the time of enrollment (or within the previous 6 months, if known)
- History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known)
- With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected)
- History of malignancy
- Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
- Participation in other clinical trial within the past 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Institute,Jinling Hospital
Nanjing, Jiangsu, 210000
wei ming zhu, PhD,MD, +86-25-80860137, dr_zhuweiming@126.com
About this study
Official title: A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD).
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
Read the detailed description
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
- Conditions
- Crohn's Disease
- Being tested
- azathioprine+enteral nutrition, Azathioprine
- Keywords
- Crohn's Disease, maintain remission, postoperative recurrence, surgery, living quality
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azathioprine+enteral nutritionDrug
AzathioprineDrug
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition+azathioprine | Experimental | Patients is fasting and receive enteral nutrition and azathioprine treatment. Receives: Drug: azathioprine+enteral nutrition |
| azathioprine | Experimental | Patients have regular diet and receive only azathioprine treatment. Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of patients'CDAI.
Measured: at 0 week, the 4 weeks, the 8 weeks, the 12weeks
patients' endoscopic score(Rutgeerts score).
Measured: at the 12weeks
Secondary outcomes (3)
The change of haematological inflammation marker(CRP,ESR)
Measured: at 0 week, the 4 weeks, the 8 weeks, the 12weeks
The change of patients'IBDQ.
Measured: at 2 week, the 6 weeks, the 12 weeks
The change of blood routine examination and blood biochemistry.
Measured: at 0 week,4 weeks,8 weeks,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiming, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823042
- Sponsor's protocol ID
- CDS-2
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD).
- ClinicalTrials.gov ID
- NCT01823042
- Acronym / sponsor ID
- CDS-2
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, maintain remission, postoperative recurrence, surgery, living quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 4 Apr 2013 (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.
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
Detailed description
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition+azathioprine | Experimental | Drug: azathioprine+enteral nutritionPatients is fasting and receive enteral nutrition and azathioprine treatment. |
| azathioprine | Experimental | Drug: AzathioprinePatients have regular diet and receive only azathioprine treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
- Lesions located in ileum or ileocecal region
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Body weight between 40 and 100 kg, inclusive.
Key exclusion criteria (14 listed)
- Bacterial,viral or other microbial infection(including HIV)
- any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs
- any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab.
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 |
|---|---|---|
| azathioprine+enteral nutrition | Drug | enteral nutrition+azathioprine |
| Azathioprine | Drug | azathioprine |
Primary outcome
The change of patients'CDAI.
Time frame: at 0 week, the 4 weeks, the 8 weeks, the 12weeks
patients' endoscopic score(Rutgeerts score).
Time frame: at the 12weeks
3 secondary outcomes
The change of haematological inflammation marker(CRP,ESR)
Time frame: at 0 week, the 4 weeks, the 8 weeks, the 12weeks
The change of patients'IBDQ.
Time frame: at 2 week, the 6 weeks, the 12 weeks
The change of blood routine examination and blood biochemistry.
Time frame: at 0 week,4 weeks,8 weeks,12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing azathioprine+enteral nutrition and Azathioprine 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 Apr 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of patients'CDAI. (time frame: at 0 week, the 4 weeks, the 8 weeks, the 12weeks). The study lists 2 primary outcomes in all. 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 4 Apr 2013.