NCT04034758

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

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-a Multi-center Double-blind RCT Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 first affiliated Hospital of Zhengzhou University will be screened for study inclusion and exclusion criteria. All consenting patients will 2:1 randomized into SQIMC-md treatment group or Placebo group. Three dose of SQIMC-md capsule will be orally administrated on day1, day2 and day3. Follow-up will be performed every 4 weeks and last for 12weeks. Full dose of 5-ASA is orally administrated simultaneously during the study. Clinical data and outcome will be collected and documented in electronic case reported form (eCRF). FMT DONORS: Potential healthy adult stool donors (between 18 and 28 years of age) will be recruited by the research staff. They will be asked to volunteer for the screening and regularly supply stool samples according to the study protocol.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-30
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-07-26
• Last updated: 2019-08-13