Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|The Second Hospital of Nanjing Medical University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Faming Zhang, MD,PhD|
|Principal Investigator Affiliation||The Second Hospital of Nanjing Medical University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate|
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.
Active Comparator: Mesalazine conventional enema
Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.
Experimental: Mesalazine TET enema
Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.
Active Comparator: Compound Glutamine conventional enema
Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Experimental: Compound Glutamine TET enema
Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Experimental: Compound Glutamine and Mesalazine TET enema
Participants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.
Device: - The Colonic Transendoscopic enteral Tubing.
The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).
Drug: - Glutamine
The medications were infused into the colon
Drug: - Mesalazine
The medications were infused into the colon
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