[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cd---crohns-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cd---crohns-disease":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,82,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100643065","phase-1-a-phase-i-study-to-evaluate-the-safetytolerability-of-bdhk-2009-tablets-in-healthy-adult-100643065",false,"NCT07632573","A Phase I Study to Evaluate the Safety\u002FTolerability of BDHK-2009 Tablets in Healthy Adult","A Phase I Clinical Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics\u002FPharmacodynamics of BDHK-2009 Tablets in Healthy Adult Participants: a Randomized, Double-blind, Placebo-controlled, Single-dose\u002FMultiple-dose Escalation Study.","Inclusion Criteria:\n\n\\- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily participate in the trial, and understand and sign the informed consent form.\n\n2\\. Healthy participants aged 18 to 55 years (inclusive), regardless of gender. 3. Weight ≥ 50 kg (for males) and ≥ 45 kg (for females), with a body mass index (BMI) of 18-26 kg\u002Fm².\n\n4\\. At screening, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, serological virology, thyroid function, etc.) results are either within normal limits or, if abnormal, not clinically significant.\n\n5\\. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening and baseline, and must not be pregnant, lactating, or planning pregnancy during the study period. WOCBP must agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product (whichever is longer).\n\n1. WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;\n2. Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery. Postmenopausal is defined as the absence of menstruation for ≥ 12 months without alternative medical intervention. Follicle-stimulating hormone (FSH) testing will be performed for subjects with uncertain status, and FSH \\> 40 mIU\u002FmL can confirm menopause.\n\n   6\\. Male participants with partners of childbearing potential are eligible for the study only if they agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product, and agree not to donate sperm during this period. In addition, male participants with partners of childbearing potential must use condoms continuously until at least 90 days after the last dose of the investigational product (whichever is longer).\n\n   Exclusion Criteria:\n   * 1\\. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the participant's participation in the study, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder.\n\n     2\\. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, psychiatric, thyroid, or other disorders, as determined by the investigator to be unsuitable for participation in this study.\n\n     3\\. Presence or suspected presence of active viral, bacterial, fungal, or parasitic infection.\n\n     4\\. History of recurrent or chronic infections.\n\n     5\\. Participants with acute illness within 2 weeks prior to screening; participants with clinically significant infections (e.g., upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; participants with evidence of any infection within 7 days prior to screening; participants with a history of herpes simplex infection or recurrent (\\>1 episode) herpes zoster or disseminated herpes zoster.\n\n     6\\. History of epidemic meningococcal infection.\n\n     7\\. History of splenectomy or functional asplenia.\n\n     8\\. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody.\n\n     9\\. Participants with a history of active tuberculosis or evidence of active or latent tuberculosis infection at screening.\n\n     10\\. Participants with a history of allergic tendencies, such as asthma, atopic dermatitis, chronic urticaria, or allergic rhinitis, or with allergies to two or more medications, foods, or pollens; participants with a history of hypersensitivity to the investigational drug or any of its components or to drugs with the same mechanism of action, or with clinically significant allergy history as determined by the investigator to be ineligible for enrollment.\n\n     11\\. Participants who have participated in another interventional clinical study and received an interventional treatment (including investigational drugs and investigational medical devices) within 30 days prior to the first dose of the study drug, or within 5 half-lives of the study drug (whichever is longer).\n\n     12\\. Participants with a history of drug abuse within 12 months prior to screening, or participants with positive urine drug screening results.\n\n     13\\. Participants who have used any strong inducers or strong inhibitors of the hepatic metabolic enzyme CYP3A within 14 days or 5 half-lives prior to administration of the investigational drug (whichever is longer).\n\n     14\\. Participants who have used any prescription medications within 14 days prior to administration of the investigational drug, or any over-the-counter medications, herbal medicines, or dietary supplements within 7 days prior to administration of the investigational drug, unless the investigator determines that the medication is not clinically significant.\n\n     15\\. Participants who have consumed any foods or beverages containing substances that may induce or inhibit hepatic metabolic enzymes (such as grapefruit, Seville orange, or star fruit, etc.) within 7 days prior to administration of the investigational drug, or who are unable to avoid consumption of foods or beverages containing caffeine within 48 hours prior to administration of the investigational drug and throughout the inpatient study period.\n\n     16\\. Participants who consumed more than 14 units of alcohol per week within 1 month prior to screening (1 unit of alcohol is approximately equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), or who consumed any alcohol products within 24 hours prior to dosing, or who have positive alcohol screening test results.\n\n     17\\. Heavy smokers or participants who smoked more than 5 cigarettes per day within 3 months prior to dosing, and who are unable to abstain from using more than 5 tobacco or nicotine-containing products (including nicotine patches) per week from screening through the end of the study.\n\n     18\\. Participants who donated blood or experienced blood loss ≥ 200 mL within 1 month prior to screening or dosing, or who donated blood or experienced blood loss ≥ 400 mL within 3 months prior to dosing, or who have difficult venous access or are unable to tolerate blood sampling.\n\n     19\\. At screening or baseline, 12-lead electrocardiogram (ECG) findings showing clinically significant abnormalities, including but not limited to: QTcF \\> 450 ms, or other arrhythmias or morphological abnormalities as determined by the investigator that may increase participant risk or interfere with data interpretation.\n\n     20\\. Participants with dysphagia or special dietary requirements who are unable to accept a standardized diet (e.g., severe food allergies).\n\n     21\\. Participants who have undergone major surgical procedures within 3 months prior to screening or who are planning to undergo surgery during the trial period.\n\n     22\\. Participants who have received vaccination within 8 weeks prior to screening, or who plan to receive vaccination during the study or within 8 weeks after administration of the study drug.\n\n     23\\. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.",[28,29,30,31,32],"Ulcerative Colitis (UC)","Ulcerative Colitis (Disorder)","Ulcerative Colitis Acute","IBD (Inflammatory Bowel Disease)","CD - Crohn's Disease",[34,35,36,37,38,39],"Crohn's disease","Ulcerative Colitis","Inflammatory Bowel Disease","IBD","CD","UC","RECRUITING","2026-06-02",{"date":43,"type":44},"2026-06-08","ACTUAL",{"date":46,"type":44},"2026-05-18",{"date":48,"type":22},"2027-02-28",{"name":50,"class":51},"Benethera (Shaoxing) Biotechnology Co., Ltd.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":52},"100627086","guselkumab-vs-ustekinumab-in-stricturing-crohns-disease-100627086","NCT07444060","Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease","Efficacy of Guselkumab Versus Ustekinumab in Stricturing Crohn's Disease: A Multicenter, Prospective, Observational Cohort Study","Inclusion Criteria:\n\n* Confirmed patients with moderate-to-severe Crohn's disease (CD), aged 18 to 80 years, receiving treatment with Guselkumab or Ustekinumab.\n* Presence of obstructive symptoms consistent with chronic or subacute intestinal obstruction within the past 8 weeks, with confirmed postprandial abdominal pain attributable to strictures, with the exclusion of: ① mild to moderate pain (postprandial abdominal pain or abdominal pain exacerbated by diet, ameliorated with abdominal bowel sounds) without nausea, vomiting or abdominal colic; ② dietary restrictions unrelated to abdominal pain.\n* Evidence of definite luminal strictures caused by the disease itself confirmed by radiographic imaging or endoscopic examination, i.e., meeting any of the following criteria:\n\n  1. Enteric computed tomography (CT): Presence of intestinal strictures on enteric CT, with two of the three following findings at the stricture site compared with the adjacent proximal bowel: ① a \\>50% reduction in luminal diameter; ② a \\>25% increase in bowel wall thickness; ③ pre-stenotic dilation \\>2.5 cm.\n  2. Endoscopic examination: Intestinal strictures that are impassable to the endoscope.\n\nExclusion Criteria:\n\n* Patients with severe disease requiring emergency surgery or endoscopic therapeutic intervention, or those judged by the attending clinician to need a switch of medication or elective surgery within 2 months, such as those with acute severe intestinal obstruction, perforation, intra-abdominal abscess, intra-abdominal adhesion, and other conditions leading to obstruction, hemorrhage, infection, etc.\n* Intestinal obstruction, intra-abdominal abscess, isolated intestinal stricture and other lesions secondary to surgery.\n* Patients who have received definitive therapeutic interventions for strictures within the past 6 months, such as endoscopic balloon dilation, stricture incision, intestinal stricture plasty, surgical\u002Fmanual anal dilatation, etc.\n* Severe patients who remain unable to take oral intake despite enteral nutrition (EN) administration for more than 2 months.\n* Patients who have used Guselkumab (GUS), Ustekinumab (UST) or other IL-23 antagonists within the past 12 months; or those with contraindications to GUS\u002FUST, or intolerance to the study medications due to other causes (e.g., allergy to IL-23 antagonists).\n* Patients with contraindications to small intestinal computed tomography (CT), such as contrast media allergy.\n* Patients with relative contraindications to biological agents, such as active tuberculosis with a positive chest X-ray for pulmonary tuberculosis or a strongly positive tuberculin skin test; a history of myocardial infarction, heart failure or demyelinating neurological diseases within the past 5 years.\n* Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.\n* Patients complicated with intestinal dysplasia (e.g., diagnosed with short bowel syndrome), colostomy or colorectal neoplasms.\n* Patients complicated with active massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, as well as intractable vomiting and severe malabsorption syndrome.\n* Pregnant or lactating patients.\n* Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.\n* Patients with psychiatric disorders, or those with insufficient educational level to fully understand the study content or unable to cooperate with the completion of the study.","80 Years",{"count":62,"type":22},100,"OBSERVATIONAL","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 Guselkumab or 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 on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.",[32,66,67],"Stricture; Bowel","IBD - Inflammatory Bowel Disease",[69,70,71],"Stricturing Crohn's Disease","Guselkumab","Ustekinumab","2026-02-25",{"date":74,"type":44},"2026-03-02",{"date":76,"type":22},"2026-03-01",{"date":78,"type":22},"2029-12-31",{"name":80,"class":81},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100624418","comparison-of-the-therapeutic-effects-of-balloon-assisted-enteroscopy-assisted-narrow-incision-and-balloon-dilation-in-the-treatment-of-crohns-disease-small-intestinal-stenosis-100624418","NCT07409376","Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision and Balloon Dilation in the Treatment of Crohn's Disease Small Intestinal Stenosis","CD stenosis","Inclusion Criteria:\n\n1. Age between 16 and 75 years.\n2. Diagnosis of Crohn's disease with primary or secondary small bowel stricture confirmed by imaging studies, or small bowel stricture identified by enteroscopy.\n3. Inadequate response to conventional medical therapy and step-up treatment strategies.\n4. Stricture length less than 5 cm.\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Bowel wall thickening with Limberg grade IV blood flow on intestinal ultrasound, or presence of complications such as perforation, fistula, deep ulcer, inflammatory mass, or abscess.\n2. Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.\n3. Presence of strictures in the esophagus, stomach, or duodenum.\n4. Presence of colorectal stricture or ileocecal valve stricture.\n5. Small bowel stricture complicated by abscess, fistula, or severe angulation.\n6. Patients with ≥3 small bowel strictures or stricture length ≥5 cm.\n7. Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.\n8. Pregnancy or breastfeeding.\n9. Inability to undergo endoscopic treatment.\n10. Severe coagulation disorders (platelet count \\\u003C70,000\u002FμL, INR \\>1.5).\n11. Concomitant advanced tumors or other severe organ diseases.\n12. Suspected localized intestinal malignancy.","16 Years","75 Years",{"count":62,"type":22},[93],"NA","This study is designed as a controlled trial to evaluate the efficacy of balloon-assisted enteroscopy-guided radial incision therapy for the treatment of stricturing small bowel Crohn's disease. The study aims to compare therapeutic outcomes, procedure-related complications, and recurrence rates in patients with stricturing small bowel Crohn's disease undergoing balloon-assisted enteroscopy-guided radial incision therapy. The results are expected to provide a novel and reliable treatment option for patients with stricturing Crohn's disease and to lay a foundation for improving disease-related symptoms and quality of life.",[32],[97],"Crohn's Disease; balloon-assisted enteroscopy; stricture","NOT_YET_RECRUITING","2026-02-12",{"date":101,"type":44},"2026-02-13",{"date":76,"type":22},{"date":104,"type":22},"2028-12-31",{"name":80,"class":81},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":60,"enrollmentInfo":115,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":132,"locationsCount":52},"100622554","prophylactic-dexamethasone-before-infliximab-in-moderate-to-severe-ibd-100622554","NCT07385131","Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD","Should Routine Prophylactic Dexamethasone Be Administered Before Intravenous Infliximab in Moderate-to-Severe Inflammatory Bowel Disease: A Prospective, Multicenter, Observational Cohort Study","PA","Inclusion Criteria:\n\n* Aged 14 to 80 years.\n* Confirmed cases of inflammatory bowel disease (IBD) with a definitive diagnosis of Crohn's disease (CD) or ulcerative colitis (UC), based on the diagnostic criteria specified in the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) and the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (Xi'an, 2023). The diagnosis shall be made by comprehensive analysis of clinical manifestations, laboratory tests, imaging examinations, endoscopic examinations and histopathological findings, with infectious colitis and other non-infectious colitis ruled out.\n* Moderate to severe CD: for adults aged 18 years and above, baseline Crohn's Disease Activity Index (CDAI) score \\>220 or Harvey-Bradshaw Index (HBI) score ≥5; for adolescents aged 14 to 17 years, baseline Pediatric Crohn's Disease Activity Index (PCDAI) score ≥31. Or moderate to severe UC: for adults aged 18 years and above, baseline Mayo score ≥6; for adolescents aged 14 to 17 years, baseline Pediatric Ulcerative Colitis Activity Index (PUCAI) score ≥36.\n* Not receiving immunosuppressant therapy (e.g., azathioprine) at present, with no plan to add such medications within the next two months.\n* Current glucocorticoid dosage ≤ 10 tablets, and a definite plan has been made for tapering down the dosage to complete discontinuation within the next two months.\n* Planned to receive the first dose of infliximab within the next two weeks.\n\nExclusion Criteria:\n\n* Patients with severe disease who, as judged by the attending clinician, require biological agent intensification therapy, switch therapy or elective surgery within 2 months, such as those with obvious stenosis, perforation, fistula and other conditions leading to obstruction, hemorrhage, infection, etc.\n* Patients at high risk of infusion reactions, including those with a history of any biological agent-related infusion reactions, or a history of allergy to any drugs such as penicillins, cephalosporins, sulfonamides, non-steroidal anti-inflammatory drugs (NSAIDs), contrast media, etc.\n* Patients with a definite history of food allergy, as well as a past history of asthma or urticaria.\n* Patients on chronic daily use of antihistamine antiallergic drugs such as loratadine, cetirizine, diphenhydramine, chlorpheniramine maleate tablets, terfenadine, etc.\n* Patients with relative contraindications to biological agents, such as active tuberculosis with positive chest X-ray, strongly positive purified protein derivative (PPD) skin test or positive T-SPOT test; a history of myocardial infarction, heart failure or demyelinating neurological diseases in the past 5 years, etc.\n* Patients with relative contraindications to glucocorticoids, such as active tuberculosis, severe infection, gastrointestinal ulcer, etc.\n* Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.\n* Patients complicated with massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, intractable vomiting, severe malabsorption syndrome, etc.\n* Patients with psychiatric disorders or insufficient educational level to fully understand the study content.\n* Pregnant or lactating patients.\n* Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.","14 Years",{"count":116,"type":22},300,"This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel disease (IBD). This study is designed to optimize the prophylactic strategy prior to Infliximab treatment and advocate for risk stratification-based individualized prophylaxis regimens to avoid hormonal abuse. Additionally, it will construct a risk score using biomarkers to accurately identify high-risk populations in need of prophylaxis and establish a corresponding predictive model. The study is also intended to reduce the use of unnecessary medications, shorten infusion duration and alleviate the medical burden. It is expected to provide targeted clinical support during the early stage of the disease or the course of treatment, improve the efficacy and precision of individualized treatment for patients, and reduce the physical, psychological and economic burdens caused by ineffective treatment.",[119,32,120],"Inflammatory Bowel Disease (IBD)","UC - Ulcerative Colitis",[122,123,124,125],"Infliximab","Dexamethasone","Preventive medication","Infusion reaction","2026-01-27",{"date":128,"type":44},"2026-02-03",{"date":130,"type":44},"2025-10-08",{"date":78,"type":22},{"name":80,"class":81}]