Inflammatory Bowel Disease
Conditions
Interventions
Bezoar Treatment Group 1 (Oral):Oral mesalazine (>2.4g/d) + 200mg bezoar (100mg/capsule ×2) once daily for 12 weeks.
Bezoar Treatment Group 2 (Sublingual):Oral mesalazine (>2.4g/d) + sublingual bezoar 200mg (100mg/capsule ×2) once daily for 12 weeks.
Placebo (PRO) Oral Group:Oral mesalazine (>2.4g/d) + oral placebo (2 capsules/bottle) once daily for 12 weeks.
Placebo (PRO) Sublingual Group:Oral mesalazine (>2.4g/d) + sublingual placebo (2 capsules/bottle) once daily for 12 weeks.
Sponsors
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male or female aged 18-65 years (inclusive). 2) Confirmed diagnosis of IBD (CD/UC) with clinical, endoscopic, and histopathological evidence. 3) Active CD patients with CDAI 150-450 or active UC patients with Mayo score 3-10. 4) Ability to provide written informed consent and comply with protocol requirements. 5) Good general health confirmed by medical history, lab tests, physical exam, and ECG.
Exclusion criteria
Exclusion criteria: 1) Allergy to bezoar, excipients or placebo components. 2) Toxic megacolon at screening. 3) History of extensive, subtotal/total colectomy. 4) Current ileostomy, colostomy or symptomatic intestinal strictures. 5) Anticipated need for surgery during study. 6) Unresected adenomatous polyps or colonic dysplasia. 7) Malignancy history or uncontrolled comorbidities. 8) Abnormal lab results: a. Hemoglobin 1200×10^9/L d. AST/ALT >1.5×ULN f. Total bilirubin =26µmol/L (excluding Gilbert's) g. Creatinine >1.4mg/dL (F)/1.6mg/dL (M) h. Clinically significant ECG abnormalities 9) Other clinically significant lab abnormalities 10) Positive pregnancy test 11) Lactating or planning pregnancy 12) Inability to comply with study visits 13) Recent participation in other interventional trials
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Week 4,12 clinical response rate;Week 4,8,12 clinical remission rate;Week 4,8,12 changes in C-reactive protein/fecal calprotectin from baseline;Week 4,8,12 proportion with >50% fecal calprotectin reduction from baseline;Week 4,8,12 changes in blood/feces/saliva/urine glutathione/MDA from baseline;Week 4,8,12 proportion with >50% glutathione/MDA reduction from baseline;Week 4,8,12 changes in CRP, ESR, IFN-?, TNF-a, IL-10, IL-6, IL-4, IL-2 from baseline;Week 4,8,12 proportion achieving Inflammatory Bowel Disease Questionnaire remission (=170);Week 4,8,12 changes in 36-Item Short Form Health Survey, EuroQol-5 Dimensions?, anxiety/depression scores from baseline;Week 12 endoscopic response rate;Week 12 endoscopic remission rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Week 8 clinical response rate; | — |
Countries
China
Contacts
Public ContactLiao Jiazhi
Department of Gastroenterology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed