Inflammatory Bowel DiseasesNCT04761952
N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease
A study testing azathioprine, infliximab and N-3 Polyunsaturated Fatty Acids in people with Inflammatory Bowel Diseases and Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Crohn's disease (CD) is a chronic recurrent intestinal inflammation involving the whole digestive tract, with high disability rate, high surgical rate and high recurrent rate postoperatively. Preventing postoperative recurrence in CD patients is an important clinical problem needed urgent intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Polyunsaturated Acid Lipidosis
- What is being tested?
- azathioprine, infliximab and N-3 Polyunsaturated Fatty Acids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2021to 31 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD patients undergoing partial resection，anastomosis or enterostomy.
- age ≥18 to ≤80 years;
- have indications of AZA or IFX application (according to the consensus of ECCO 2016 years);
- Preoperative diagnosis CD, must provide the biopsy pathological record which accords with the CD diagnosis;
- If the subject is a woman of childbearing age, pregnancy tests must be conducted at baseline to exclude pregnancy, and the trial process must follow the contraceptive advice of this project
- subjects must be able and willing to provide written informed consent and comply with the requirements of this research program
Who cannot join
- patients without indications use of AZA or IFX;
- isolated colon CD patients;
- patients who can't take long-term oral intervention of n-3PUFA;
- patients diagnosed with short bowel or short bowel syndrome;
- patients with severe, progressive or uncontrolled kidney, liver, blood or endocrine diseases;
- postoperative abdominal infection, anastomotic fistula and other complications;
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- there's an infection, Such as Clostridium difficile toxin or other intestinal pathogens infection, active tuberculosis or intestinal tuberculosis, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C;
- patients with a history of gastrointestinal dysplasia; patients with
- TPMT gene mutations or low activity;
- patients who has already participated in other clinical trial.
About this study
Official title: N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease：a Prospective Randomized Controlled Trial
Crohn's disease (CD) is a chronic recurrent intestinal inflammation involving the whole digestive tract, with high disability rate, high surgical rate and high recurrent rate postoperatively. Preventing postoperative recurrence in CD patients is an important clinical problem needed urgent intervention. Azathioprine (AZA) and infliximab (IFX) effectively prevent postoperative recurrence in CD patients, but the postoperative recurrence rate is still as high as 41%. Oral supplement of n-3 polyunsaturated fatty acids (n-3 PUFA) owns the advantages of high compliance and low economic cost. We aim to evaluate the effect of routine treatment (AZA/IFX) combined with long-term dietary n-3PUFA on the prevention and treatment of postoperative recurrence of CD, which help optimize the treatment strategy for the prevention of postoperative recurrence.
- Being tested
- azathioprine, infliximab, N-3 Polyunsaturated Fatty Acids
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Neuronal Ceroid-Lipofuscinoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azathioprineDrug
Also called AZA
daily orally
infliximabDrug
Also called IFX
intravenously, at 0, 2,6 weeks with every 8-week-interval later
N-3 Polyunsaturated Fatty AcidsDrug
Also called n-3PUFA
Ethyl polyenoate capsule is given as drug intervention. The main components are ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoate (DHA-E), both of which will transform into ethyl eicosapentaenoate (EPA) and ethyl docosahexaenoate (DHA). Drug dose is 0.25 g EPA-E\&DHA-E; per capsule one at a time, Three times a day.
| Study group | Role | What they receive |
|---|---|---|
| n-3PUFA treatment group | Experimental | On the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative. Receives: Drug: azathioprine; Drug: infliximab; Drug: N-3 Polyunsaturated Fatty Acids |
| Conventional treatment group | Placebo comparator | Treatment of azathioprine (daily orally) or infliximab (intravenously, at 0, 2,6 weeks with every 8-week-interval later) was given since 2-week-postoperative till 1-year-postoperative. Receives: Drug: azathioprine; Drug: infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year postoperative anastomotic recurrence rate
anastomotic recurrence including endoscopic recurrence and imaging recurrence
Measured: 1 year
Secondary outcomes (5)
3 months postoperative anastomotic recurrence rate
anastomotic recurrence including endoscopic recurrence and imaging recurrence
Measured: 3 months
clinical recurrence rate
CDAI score larger than 150
Measured: 3 months，1 year
Inflammatory load
level of serum C- reactive protein
Measured: 3 months，1 year
Inflammatory load
level of serum fecal calprotectin
Measured: 3 months，1 year
Life quality SF-36
inflammatory bowel disease questionnaire and health survey summary table SF-36
Measured: 3 months，1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start13 Feb 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761952
- Sponsor's protocol ID
- 2020ZSLYEC-292
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease：a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04761952
- Acronym / sponsor ID
- 2020ZSLYEC-292
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 13 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Feb 2021 (actual)
- 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 chronic recurrent intestinal inflammation involving the whole digestive tract, with high disability rate, high surgical rate and high recurrent rate postoperatively. Preventing postoperative recurrence in CD patients is an important clinical problem needed urgent intervention. Azathioprine (AZA) and infliximab (IFX) effectively prevent postoperative recurrence in CD patients, but the postoperative recurrence rate is still as high as 41%. Oral supplement of n-3 polyunsaturated fatty acids (n-3 PUFA) owns the advantages of high compliance and low economic cost. We aim to evaluate the effect of routine treatment (AZA/IFX) combined with long-term dietary n-3PUFA on the prevention and treatment of postoperative recurrence of CD, which help optimize the treatment strategy for the prevention of postoperative recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3PUFA treatment group | Experimental | Drug: azathioprine, Drug: infliximab, Drug: N-3 Polyunsaturated Fatty AcidsOn the basis of routine treatment, oral supplement of n-3PUFA was given to CD patients since 2-week-postoperative till 1-year-postoperative. |
| Conventional treatment group | Placebo comparator | Drug: azathioprine, Drug: infliximabTreatment of azathioprine (daily orally) or infliximab (intravenously, at 0, 2,6 weeks with every 8-week-interval later) was given since 2-week-postoperative till 1-year-postoperative. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CD patients undergoing partial resection，anastomosis or enterostomy.
- age ≥18 to ≤80 years;
- have indications of AZA or IFX application (according to the consensus of ECCO 2016 years);
- Preoperative diagnosis CD, must provide the biopsy pathological record which accords with the CD diagnosis;
- If the subject is a woman of childbearing age, pregnancy tests must be conducted at baseline to exclude pregnancy, and the trial process must follow the contraceptive advice of this project
Key exclusion criteria (10 listed)
- patients without indications use of AZA or IFX;
- isolated colon CD patients;
- patients who can't take long-term oral intervention of n-3PUFA;
- patients diagnosed with short bowel or short bowel syndrome;
- patients with severe, progressive or uncontrolled kidney, liver, blood or endocrine diseases;
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 |
|---|---|---|
| azathioprineAlso: AZAdaily orally | Drug | Conventional treatment group, n-3PUFA treatment group |
| infliximabAlso: IFXintravenously, at 0, 2,6 weeks with every 8-week-interval later | Drug | Conventional treatment group, n-3PUFA treatment group |
| N-3 Polyunsaturated Fatty AcidsAlso: n-3PUFAEthyl polyenoate capsule is given as drug intervention. The main components are ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoate (DHA-E), both of which will transform into ethyl eicosapentaenoate (EPA) and ethyl docosahexaenoate (DHA). Drug dose is 0.25 g EPA-E\&DHA-E; per capsule one at a time, Three times a day. | Drug | n-3PUFA treatment group |
Primary outcome
1 year postoperative anastomotic recurrence rate
Time frame: 1 year
anastomotic recurrence including endoscopic recurrence and imaging recurrence
5 secondary outcomes
3 months postoperative anastomotic recurrence rate
Time frame: 3 months
clinical recurrence rate
Time frame: 3 months，1 year
Inflammatory load
Time frame: 3 months，1 year
Inflammatory load
Time frame: 3 months，1 year
Life quality SF-36
Time frame: 3 months，1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing azathioprine, infliximab and N-3 Polyunsaturated Fatty Acids in people with Inflammatory Bowel Diseases and Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 6 inclusion and 10 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
1 year postoperative anastomotic recurrence rate (time frame: 1 year). 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 21 Feb 2021.