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

NCT04034758 | Unknown

• 1 other identifier: 2019CR209
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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-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

Ulcerative Colitis

Keywords

Fecal microbiota transplantation; SQIMC-md; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Clinical response rate at week 8 after SQIMC-md treatment.

  Assess efficacy of SQIMC-md FMT treatment with the aid of the Mayo score for Ulcerative Colitis clinical disease severity and response rate at week 8 after SQIMC-md treatment. Mayo score (Disease activity index) for Ulcerative Colitis. Total range for complete Mayo score 0-12 (sum from 4 subscales below) and partial Mayo score 0-9 (sum from 1,2 and 4 subscales below): Each subscale for mayo score: 1. Stool frequency: 0-3 2. Rectal bleeding: 0-3 3. Mayo endoscopic score: 0-3 4. Estimation from physician: 0-3 Clinical response rate is defined as a decrease of ≥ 3 points and at least 30% from baseline in the Mayo score, with an accompanying decrease of ≥ 1 point in the subscore for rectal bleeding or an absolute subscore ≤ 1 for rectal bleeding

  8 weeks

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events

  12 weeks

• clinical response rate at week4 and week12

  week4 and week12

• the remission rate at week12

  12 weeks

• Mean (or median) decrease of fecal calprotectin

  12 weeks

• Mean (or median) change from baseline in Inflammatory Bowel Disease Questionnaire （IBDQ） total score and subscore at week 12

  12 weeks

Study Arms (2)

Placebo capsule arm

PLACEBO COMPARATOR

Oral administration of 30 placebo capsule containing edible pigmented starch together with full dose of oral 5-Aminosalicylic acid(5-ASA).

Procedure: placebo capsule

SQIMC-md FMT arm

ACTIVE COMPARATOR

Oral administration of 30 SQIMC-md capsules containing 2\*10\^13 copies of prepared fecal microbiota lyophilized powder from multiple healthy donors' fresh feces together with full dose of oral 5-Aminosalicylic acid(5-ASA).

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

Interventions

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

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

SQIMC-md FMT arm

placebo capsule PROCEDURE

Oral administration of 30 placebo capsule containing edible pigmented starch

Placebo capsule arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Related Publications (1)

• Huang T, Xu J, Wang M, Pu K, Li L, Zhang H, Liang Y, Sun W, Wang Y. An updated systematic review and meta-analysis of fecal microbiota transplantation for the treatment of ulcerative colitis. Medicine (Baltimore). 2022 Jul 29;101(30):e29790. doi: 10.1097/MD.0000000000029790.

  PMID: 35905229 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Fang Xiao, Doctoral

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Xiao, Doctoral

CONTACT

008615927368783; christina_fx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 26, 2019
• Study Start: August 30, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 13, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: The data will be available after we finish the trial and the publication. The sharing of the data is planned to lasted for one year.
• Access Criteria: Not decided yet.