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Compares treatment options for Crohn Disease (CD)
Official title Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.
ClinicalTrials.gov ID: NCT06912815
What this study is testing
What is ustekinumab and semi enteral nutrition?
ustekinumab and semi enteral nutrition is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn disease (cd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.