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Safety and Efficacy of Heterologous FMT by SQIMC-md Capsule in Mild-moderate Ulcerative Colitis Patients

NCT04034758 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2019-08-13

No results posted yet for this study

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-moderate ulcerative colitis patients who fail to achieve clinical remission over 4 weeks after full dose 5-Aminosalicylic acid(5-ASA). Intestinal microbiota transplant for FMT will be prepared from multiple healthy donors and prepared by standardized procedure with fixed quantitative dosage. This strategy might offer a novel and safe therapeutic approach for these patients before step up to corticosteroid, immunosuppressant or biologics therapy.

Conditions

Interventions

PROCEDURE

Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)

heterologous fecal microbiota transplantation (FMT) by Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)

PROCEDURE

placebo capsule

Oral administration of 30 placebo capsule containing edible pigmented starch

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Fang Xiao, Doctoral · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2023-12-31
Completion
2023-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034758 on ClinicalTrials.gov