AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease

Recruitingn/aAges 18 Years - 65 YearsAllSecond Affiliated Hospital, Zhejiang University, โ€ฆ
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Clinical diagnosis of moderate to severe Crohn's disease * Obstructive symptoms within the last eight weeks * A single or several lumen stricture(s) identified by radiological imaging or endoscopy * For strictures identified by CT enterograph defined as a lesion with combination of a reduction of luminal narrowing \>50%, an increase in bowel wall thickness \>25% relative to non-affected bowel and pre-stricture dilation \>3.0 cm * For strictures identified during endoscopic procedure defined by intestinal strictures with a lumen diameter โ‰ค12 mm or even inability to pass the endoscope across the narrowing Exclusion Criteria: * Requirement of urgent surgery or endoscopic intervention within 2 months as judged by the clinician * Symptoms or signs of perforation such as active perianal sepsis, abdominal abscess, intestinal fistula, and abdominal adhesions * Intestinal obstruction caused by surgery, intra-abdominal abscess, isolated intestinal stricture * Effective treatments for stricture in the past half a year, such as endoscopic balloon dilatation, intestinal stricture plasty, surgery/manual anal dilatation, etc. * Unable to eat after using enteral nutrition for more than 2 months * History of ustekinumab (UST) or other IL-23 antagonists use in the past 12 months * CT enterograph contraindications, such as allergy to contrast media * Relative contraindications of biological agents, such as pulmonary tuberculosis-positive chest X-ray or active tuberculosis with strong positive tuberculin skin test, myocardial infarction, heart failure, or demyelinating neurological disease * Currently suffering from a solid tumor, lymphoma, or melanoma and undergoing chemotherapy or radiation therapy * Combination of intestinal dysplasia (eg, diagnosed with short bowel syndrome), colostomy, or colorectal tumors * Combination of active gastrointestinal bleeding, shock, severe diarrhea, refractory vomiting and severe malabsorption syndrome * Combination of severe liver and kidney dysfunction * Coexistence of bacterial or viral active infection * Pregnant or breastfeeding * Severe hemodynamics, unstable vital signs or presence of rapidly progressive or end-stage disease, expected to be fatal during the course of the study
๐Ÿ’Š

What it tests

  • Ustekinumab
๐Ÿ“

Where

8 sites
Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital
Beijing, China
Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences
Chongqing, China
Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Department of Gastroenterology, Huai'an First People's Hospital
Huai'an, China
Department of Gastroenterology, Second Affiliated Hospital of Soochow University
Suzhou, China
Department of Gastroenterology, Affiliated Hospital of Yangzhou University
Yangzhou, China
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy