Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.
Not applicable · Testing ustekinumab and semi enteral nutrition and Exclusive enteral nutrition · 1 site · Xiang Gao
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing ustekinumab and semi enteral nutrition (a biologic) and Exclusive enteral nutrition as a possible treatment. Condition(s) listed: Crohn Disease (CD).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- CD patients with surgical indications, who are scheduled for partial intestinal resection and anastomosis;
- CD patients diagnosed prior to surgery;
- Patients aged 18-65;
Plus 5 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 184 participants are expected to take part.
- Start date: 2024-08-01.
- Main results expected around 2026-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Preoperative clinical remission rate (From enrollment to the end of treatment at 6 weeks)
In the researchers’ words
Ustekinumab (UST) is a novel biologic agent that targets and binds to Interleukin-12 (IL-12) and Interleukin-23 (IL-23), and is approved for inducing and maintaining remission in Crohn Disease(CD). Currently, it is believed that the use of UST for the preoperative treatment of CD patients is generally safe and does not increase surgical complications, and it can be used for preoperative treatment of CD.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | Xiang Gao |
| Enrollment | 184 (estimated) |
| Start date | 2024-08-01 |
| Primary completion (est.) | 2026-09 |
| First posted | 2025-04-06 |
| Last updated | 2025-04-06 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06912815 |
Interventions
- ustekinumab and semi enteral nutrition (Biological)
Preoperative treatment optimization involves a single intravenous induction with UST, followed by 6 weeks of oral/nasal feeding with semi-enteral nutrition. - Exclusive enteral nutrition (Other)
Preoperative optimized treatment with 6 weeks of oral/nasal feeding of exclusive enteral nutrition alone.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.