Status:
UNKNOWN
Safety and Efficacy of Heterologous FMT by SQIMC-md Capsule in Mild-moderate Ulcerative Colitis Patients
Lead Sponsor:
Tongji Hospital
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study aims to assess the safety and efficacy of heterologous fecal microbiota transplantation (FMT) by Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md) in mild-moder...
Detailed Description
All candidates for mild-moderate ulcerative colitis treated in Dept. Gastroenterology, Tongji Hospital, Tongji Medical College of HUST, the second Xiangya Hospital of central south university and the ...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of ulcerative colitis based on clinical symptoms, as well as laboratory and colonoscopic findings, including histopathologic results of the intestinal mucosa.
- Ulcerative Colitis complete Mayo score range from 4 to 10 \[mild-moderate activity\] and Mayo endoscopic score ≥2 as assessed within 4 weeks prior to enrollment and clinical symptoms that are at least stable.
- Patients failed to acquire clinical remission after full dose and adequate course (4 weeks) of 5-ASA or precursors treatment.
- Patients ≥ 18 and \< 70 years of age are eligible for this trial.
- All patients must sign a written informed consent document. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion
- Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) or other severe immunodeficiency
- Patients with severe prior allergic reaction to food or supplementary material of placebo will be excluded from the protocol.
- Patients who are pregnant or lactating will be excluded from the protocol.
- Suspected as CMV or EBV colitis by endoscopic findings and proved by immunohistochemistry and biopsy PCR.
- Decompensated life-threatening disease including but not restricted to liver cirrhosis (bleeding varices, ascites, encephalopathy or icterus), heart attack, malignancy and so on.
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04034758
Start Date
August 30 2019
End Date
December 31 2023
Last Update
August 13 2019
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