Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

Nanjing Medical University

Status and phase: Unknown; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Saline; Drug: fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02998112

FMT-UC-121101

Details and patient eligibility

About

To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the efficacy and safety of FMT for patients with moderate or severe UC.

Full description

1. Patients with moderate to severe UC will be screened (Mayo>6）.
2. Participants will be divided into control and study groups by double blind.
3. Control group and study group will receive a colonic endoscopy evaluation. And a TET tube will be fixed at ileocecum.
4. Enema with 5-ASA 4g/day for 7days by TET will be performed as basic therapy for both control and study group. Study and control group will be given with fecal microbiota suspension and equal volume of saline by TET for three times every other day in one week.
5. The follow-up will be performed at 1 week, 4 weeks and 12 weeks after first treatment. All the participants will receive a endoscopy evaluation at 12 weeks. Clinical remission, clinical improvement and safety are the primary endpoint at 12 weeks; Intestinal microbiota changing is recognized as the secondary endpoint.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active, moderate to severe severity (Mayo score more than 6)
• Safety using history of 5-ASA.
• Able to undergo endoscopy examination.

Exclusion criteria

• Immunosuppressive drugs and glucocorticoids using in 4 weeks
• Antibiotic using in 7 days
• High risk of toxic megacolon
• Colon cancer or neoplasia in pathophysiology
• Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week

Treatment:

Drug: Saline

Study group

Experimental group

Description:

5-ASA 4g/day enema through TET for 1 week; 200ml fecal microbiota suspension infusion through TET for 3 times every other day in one week

Treatment:

Drug: fecal microbiota transplantation