Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
Conditions
Keywords
Inflammatory Bowel Disease, Transendoscopic Enteral Tubing, Mesalazine, Compound Glutamine
Brief summary
Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).This clinical trail aims to evaluate the efficacy and safety of Mesalazine and Compound Glutamine enema in the treatment of Ulcerative Colitis through Colonic TET.
Detailed description
Enema is a conventional treatment for Ulcerative Colitis(UC). Mesalazine is suitable for the patients with mild to moderate UC.But for the UC with extending lesions, the conventional anema with Mesalazine or other medicine can not very effective.Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).Compared with the conventional enema, which is only used for local administration, the Colonic TET enema can achieve total colonic administration.This study aims to evaluate the efficacy and safety of Colonic TET for UC.Patients in this study will be divided into 5 groups according to certain criteria: the Mesalazine conventional enema group, the Mesalazine TET enema group, the Compound Glutamine conventional enema group, the Compound Glutamine TET enema group, the Mesalazine and Compound Glutamine TET enema group.Each group was given enema for 7 days.The primary outcome measure was the clinical remission efficacy rate in each group. The secondary outcome measure was the safety of TET.
Interventions
DEVICEThe Colonic Transendoscopic enteral Tubing.
The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).
DRUGGlutamine
The medications were infused into the colon
DRUGMesalazine
The medications were infused into the colon
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged between 18 and 65 2. Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions) 3. Patients who can fully understand this study and voluntarily sign an informed consent; 4. Accept re-examination, follow-up examination and specimen retention in time 5. Suitable for colonoscopy and colonic TET; 6. A history of using Mesalazine and Compound Glutamine safely
Exclusion criteria
1. Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks 2. Cyclosporine was used within 4 weeks 3. Antibiotics or probiotics was used within 4 weeks 4. Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology 5. History of colon surgery 6. Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident 7. Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival 8. Patients with anxiety, depression, mental or legal disabilities 9. History of suspected or proven alcohol/drug abuse 10. Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy 11. Patients who are allergic to salicylic acid or aspirin 12. Patients with food allergies 13. Patients who are preparing to become pregnant during the study period 14. Patients considered by the researchers as unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate | 10-days | The frequency of defecation and hematochezia score were both zero |
| The effective rate | 10-days | Part of the total Mayo score was 3 points lower than the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 10-days | Number of participants with treatment-related adverse events |
Countries
China
Contacts
Primary ContactFaming Zhang, MD,PhD
Outcome results
None listed