Trials / Unknown
UnknownNCT04761952
N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease
N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease：a Prospective Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 236 (estimated)
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | azathioprine | daily orally |
| DRUG | infliximab | intravenously, at 0, 2,6 weeks with every 8-week-interval later |
| DRUG | N-3 Polyunsaturated Fatty Acids | 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. |
Timeline
- Start date
- 2021-02-13
- Primary completion
- 2022-12-31
- Completion
- 2023-12-31
- First posted
- 2021-02-21
- Last updated
- 2021-02-21
Source: ClinicalTrials.gov record NCT04761952. Inclusion in this directory is not an endorsement.