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

Primary Purpose

Ulcerative Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)
placebo capsule
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Fecal microbiota transplantation, SQIMC-md, Ulcerative colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Patients failed to acquire clinical remission after full dose and adequate course (4 weeks) of 5-ASA or precursors treatment.
  4. Patients ≥ 18 and < 70 years of age are eligible for this trial.
  5. All patients must sign a written informed consent document. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria:

  1. Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) or other severe immunodeficiency
  2. Patients with severe prior allergic reaction to food or supplementary material of placebo will be excluded from the protocol.
  3. Patients who are pregnant or lactating will be excluded from the protocol.
  4. Suspected as CMV or EBV colitis by endoscopic findings and proved by immunohistochemistry and biopsy PCR.
  5. Decompensated life-threatening disease including but not restricted to liver cirrhosis (bleeding varices, ascites, encephalopathy or icterus), heart attack, malignancy and so on.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo capsule arm

    SQIMC-md FMT arm

    Arm Description

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

    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).

    Outcomes

    Primary Outcome Measures

    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: Stool frequency: 0-3 Rectal bleeding: 0-3 Mayo endoscopic score: 0-3 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

    Secondary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events
    safety of SQIMC-md FMT treatment by recording the incidence of adverse events.
    clinical response rate at week4 and week12
    Assess the efficacy of SQIMC-md FMT by response rate at week4 and week12
    the remission rate at week12
    the remission rate at week12 with the aid of mayo score or partial Mayo score. Clinical remission rate at week 12 after treatment (clinical remission is defined as a Mayo score of ≤ 2 points and no single score > 1 point
    Mean (or median) decrease of fecal calprotectin
    Assess the efficacy of SQIMC-md FMT measured by the drop of fecal calprotectin.
    Mean (or median) change from baseline in Inflammatory Bowel Disease Questionnaire （IBDQ） total score and subscore at week 12
    IBDQ includes 32 questions. The questions are grouped into four categories (subscore): Bowel symptoms (B), Systemic symptoms (S), Emotional function (E) and Social function (SF). Response options are consistently presented as seven-point scales (1-7). Total score is defined as the sum of subscore of four categories.

    Full Information

    First Posted
    July 9, 2019
    Last Updated
    August 8, 2019
    Sponsor
    Tongji Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04034758
    Brief Title
    Safety and Efficacy of Heterologous FMT by SQIMC-md Capsule in Mild-moderate Ulcerative Colitis Patients
    Acronym
    SQIMC-md
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tongji Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis
    Keywords
    Fecal microbiota transplantation, SQIMC-md, Ulcerative colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    99 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo capsule arm
    Arm Type
    Placebo Comparator
    Arm Description
    Oral administration of 30 placebo capsule containing edible pigmented starch together with full dose of oral 5-Aminosalicylic acid(5-ASA).
    Arm Title
    SQIMC-md FMT arm
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)
    Intervention Description
    heterologous fecal microbiota transplantation (FMT) by Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)
    Intervention Type
    Procedure
    Intervention Name(s)
    placebo capsule
    Intervention Description
    Oral administration of 30 placebo capsule containing edible pigmented starch
    Primary Outcome Measure Information:
    Title
    Clinical response rate at week 8 after SQIMC-md treatment.
    Description
    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: Stool frequency: 0-3 Rectal bleeding: 0-3 Mayo endoscopic score: 0-3 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
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    safety of SQIMC-md FMT treatment by recording the incidence of adverse events.
    Time Frame
    12 weeks
    Title
    clinical response rate at week4 and week12
    Description
    Assess the efficacy of SQIMC-md FMT by response rate at week4 and week12
    Time Frame
    week4 and week12
    Title
    the remission rate at week12
    Description
    the remission rate at week12 with the aid of mayo score or partial Mayo score. Clinical remission rate at week 12 after treatment (clinical remission is defined as a Mayo score of ≤ 2 points and no single score > 1 point
    Time Frame
    12 weeks
    Title
    Mean (or median) decrease of fecal calprotectin
    Description
    Assess the efficacy of SQIMC-md FMT measured by the drop of fecal calprotectin.
    Time Frame
    12 weeks
    Title
    Mean (or median) change from baseline in Inflammatory Bowel Disease Questionnaire （IBDQ） total score and subscore at week 12
    Description
    IBDQ includes 32 questions. The questions are grouped into four categories (subscore): Bowel symptoms (B), Systemic symptoms (S), Emotional function (E) and Social function (SF). Response options are consistently presented as seven-point scales (1-7). Total score is defined as the sum of subscore of four categories.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang Xiao, Doctoral
    Phone
    008615927368783
    Email
    christina_fx@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fang Xiao, Doctoral
    Organizational Affiliation
    Tongji Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    We plan to share at least the ICF and CSR after the trial is ended. 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.
    IPD Sharing 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.
    IPD Sharing Access Criteria
    Not decided yet.
    Citations:
    PubMed Identifier
    35905229
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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