Combining Ustekinumab with Semi-Enteral Nutrition for Crohn's Disease Before Surgery
Comparative Analysis of Curative Effect Ustekinumab Combined With Semi Enteral Nutrition and Exclusive Enteral Nutrition in Preoperative Optimization of Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study
This study is testing if combining a medication called Ustekinumab with a special diet can help adults with Crohn's Disease feel better and get healthier before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | ustekinumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06912815 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining Ustekinumab, a biologic agent targeting Interleukin-12 and Interleukin-23, with semi-enteral nutrition in optimizing preoperative treatment for patients with Crohn's Disease. The approach aims to induce disease remission while improving the nutritional status of patients scheduled for surgical intervention. Eligible participants include adults aged 18-65 with a CDAI score greater than 150 who have not previously used Ustekinumab. The study will compare this combined treatment regimen against exclusive enteral nutrition to assess its potential benefits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with Crohn's Disease who are scheduled for surgery and have not previously received Ustekinumab.
Not a fit: Patients requiring emergency surgery or those who have previously failed Ustekinumab treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall health for patients with Crohn's Disease.
How similar studies have performed: While the use of Ustekinumab in Crohn's Disease is established, the specific combination with semi-enteral nutrition is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CD patients with surgical indications, who are scheduled for partial intestinal resection and anastomosis; * CD patients diagnosed prior to surgery; * Patients aged 18-65; * CDAI score of \>150; * For patients with peritoneal abscess, they must receive adequate antibiotics and drainage prior to enrollment, and be confirmed to be free of infection before enrolling in the study; * The patients agree to participate in the study and sign an informed consent form; * Patients who have not used ustekinumab prior to surgery; * Patients who have tried other treatments and found them ineffective, and plan to stop using them and schedule surgery. Exclusion Criteria: * Emergency surgery; * Had received exclusive enteral nutrition support within 3 months prior to surgery; * Unable to tolerate enteral nutrition; * Failed with UST; * Pregnant or with co-existing intestinal outside organ dysfunction, tumor, rheumatological or immunological diseases, etc.
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiang Gao
- Email: gxiang@mail.sysu.edu.cn
- Phone: +86-020-38663423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.