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MTC Versus FMT in for RCDI

Primary Purpose

Clostridiodies Difficile Infections

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MTC 01
Fecal Microbiota Transplantation (FMT)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridiodies Difficile Infections

Eligibility Criteria

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

Inclusion Criteria: Ages eligible for study: 18 years and older Able and willing to provide written informed consent History of recurrent CDI defined as 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) Subjects with a qualifying recurrent CDI episode, defined as: History of diarrhea (>=3 unformed stools per day for 2 or more consecutive days that is clinically consistent with CDI Documented positive stool test by local laboratory for toxigenic C. difficile (toxin EIA or PCR-based testing) for the current CDI episode within 60 days prior to randomization. Received a course of standard-of-care (SOC) CDI antibiotics for the most recent CDI episode (for 10 to 42 days, with exact duration, antibiotic type and dose at the discretion of the Investigator) Demonstrated adequate clinical response, defined as <= 3 unformed stools per day for 2 or more consecutive days during SOC CDI antibiotics prior to randomization. CDI symptoms started within 60 days prior to randomization. Exclusion Criteria: Female subjects who are pregnant or breastfeeding or are planning to become pregnant during the study. Women with reproductive potential should use a reliable method of birth control: Consistent use of an approved hormonal contraception (birth control pill/patches, rings); An intrauterine device (IUD); Contraceptive injection (Depo-Provera); Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam); Sexual abstinence (no sexual intercourse) or Sterilization Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment. Subjects with active gastroenteritis due to infectious causes other than CDI Subjects with allergies to ingredients present in the investigational product Prior participation in studies of investigational live biotherapeutic products or FMT within the last 6 months. History of active diarrhea associated with inflammatory bowel disease (IBD). Major gastrointestinal surgery within the last 3 months before enrollment. Use of drugs that alter gut motility. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to enrollment. Unable or unwilling to undergo a colonoscopy Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy. Anticipated immediate or upcoming surgery within 30 days Need for continued non-anti-CDI antibiotic therapy History of total proctocolectomy Patients who are unable to give informed consent Participation in a clinical trial in the preceding 30 days or simultaneously during this trial Severe food allergy (anaphylaxis or anaphylactoid-like reaction) Life expectancy < 6 months Unable to adhere to protocol requirements Patient who have received an FMT in the past year Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT Clinically significant abnormal lab values including but not limited to WBC >15 x 103/mm3, ANC <0.5 x 103/mm3, or laboratory evidence of acute kidney injury at Investigator's discretion, at screening If a patient is heavily immunosuppressed and is negative for CMV or EBV

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

High Dose MTC 01

Low Dose MTC 01

Low dose Fecal Microbiota Transplantation (FMT)

High Dose Fecal Microbiota Transplantation (FMT)

Arm Description

High dose MTC 01 is 10 x 11 CFU slurry to be administered via colonoscopy

Low Dose MTC 01 is 10 x 10 CFU slurry to be administered via colonoscopy

High dose FMT is 10 x 11 CFU slurry to be administered via colonoscopy

Low dose FMT is 10 x 10 CFU slurry to be administered via colonoscopy

Outcomes

Primary Outcome Measures

Number of treatment-related serious adverse events (SAE) as assessed by NIH grading
Number of serious adverse events per NIH grading indications. Grade 1-5, where grade 3-5 are considered severe. Mild Moderate Severe Life threatening Death Serious Adverse Event (SAE): Any adverse event that: Results in death Is life threatening, or places the participant at immediate risk of death from the event as it occurred Requires or prolongs hospitalization Causes persistent or significant disability or incapacity Results in congenital anomalies or birth defects Is another condition which investigators judge to represent significant hazards
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0, grade 1-2, where higher grades indicate higher levels of impairment. Mild Moderate Severe Life threatening Death

Secondary Outcome Measures

Percent of patients who develop Clostridioides difficile (C difficile)
Recurrence of Clostridioides difficile (C difficile) within 8 weeks of receiving treatment. The stool C difficile toxin test detects harmful substances produced by the C difficile bacterium . This infection is a common cause of diarrhea after antibiotic use. Abnormal results mean that toxins produced by C difficile are seen in the stool and are causing diarrhea.

Full Information

First Posted
June 12, 2023
Last Updated
October 16, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05911997
Brief Title
MTC Versus FMT in for RCDI
Official Title
Comparison of MTC01 vs FMT for the Treatment of Recurrent Clostridioides Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 25, 2025 (Anticipated)
Study Completion Date
May 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigating four different treatment of MTC or FMT
Detailed Description
The purpose of this research study is to compare two different treatments for patients with recurrent Clostridiodies difficile infections: MTC01 vs fecal microbiota transplantation (FMT). FMT is the transfer of bacteria from a healthy donor's colon to a recipient's colon. To do this, stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy. This treatment is now considered standard medical care for recurrent Clostridioides difficile infections. One FMT dose contains the entire collection of microbes in a healthy donor and is made up of billions of microbes. Each dose of FMT is different from the next and it is unknown exactly what microbes are present in each dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridiodies Difficile Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Four different interventions
Masking
None (Open Label)
Masking Description
All open label
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose MTC 01
Arm Type
Experimental
Arm Description
High dose MTC 01 is 10 x 11 CFU slurry to be administered via colonoscopy
Arm Title
Low Dose MTC 01
Arm Type
Experimental
Arm Description
Low Dose MTC 01 is 10 x 10 CFU slurry to be administered via colonoscopy
Arm Title
Low dose Fecal Microbiota Transplantation (FMT)
Arm Type
Active Comparator
Arm Description
High dose FMT is 10 x 11 CFU slurry to be administered via colonoscopy
Arm Title
High Dose Fecal Microbiota Transplantation (FMT)
Arm Type
Experimental
Arm Description
Low dose FMT is 10 x 10 CFU slurry to be administered via colonoscopy
Intervention Type
Drug
Intervention Name(s)
MTC 01
Intervention Description
Slurry to be administered via colonoscopy
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplantation (FMT)
Other Intervention Name(s)
Full spectrum FMT from a single donor
Intervention Description
Stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy
Primary Outcome Measure Information:
Title
Number of treatment-related serious adverse events (SAE) as assessed by NIH grading
Description
Number of serious adverse events per NIH grading indications. Grade 1-5, where grade 3-5 are considered severe. Mild Moderate Severe Life threatening Death Serious Adverse Event (SAE): Any adverse event that: Results in death Is life threatening, or places the participant at immediate risk of death from the event as it occurred Requires or prolongs hospitalization Causes persistent or significant disability or incapacity Results in congenital anomalies or birth defects Is another condition which investigators judge to represent significant hazards
Time Frame
up to 24 weeks
Title
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0, grade 1-2, where higher grades indicate higher levels of impairment. Mild Moderate Severe Life threatening Death
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Percent of patients who develop Clostridioides difficile (C difficile)
Description
Recurrence of Clostridioides difficile (C difficile) within 8 weeks of receiving treatment. The stool C difficile toxin test detects harmful substances produced by the C difficile bacterium . This infection is a common cause of diarrhea after antibiotic use. Abnormal results mean that toxins produced by C difficile are seen in the stool and are causing diarrhea.
Time Frame
within 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages eligible for study: 18 years and older Able and willing to provide written informed consent History of recurrent CDI defined as 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) Subjects with a qualifying recurrent CDI episode, defined as: History of diarrhea (>=3 unformed stools per day for 2 or more consecutive days that is clinically consistent with CDI Documented positive stool test by local laboratory for toxigenic C. difficile (toxin EIA or PCR-based testing) for the current CDI episode within 60 days prior to randomization. Received a course of standard-of-care (SOC) CDI antibiotics for the most recent CDI episode (for 10 to 42 days, with exact duration, antibiotic type and dose at the discretion of the Investigator) Demonstrated adequate clinical response, defined as <= 3 unformed stools per day for 2 or more consecutive days during SOC CDI antibiotics prior to randomization. CDI symptoms started within 60 days prior to randomization. Exclusion Criteria: Female subjects who are pregnant or breastfeeding or are planning to become pregnant during the study. Women with reproductive potential should use a reliable method of birth control: Consistent use of an approved hormonal contraception (birth control pill/patches, rings); An intrauterine device (IUD); Contraceptive injection (Depo-Provera); Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam); Sexual abstinence (no sexual intercourse) or Sterilization Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment. Subjects with active gastroenteritis due to infectious causes other than CDI Subjects with allergies to ingredients present in the investigational product Prior participation in studies of investigational live biotherapeutic products or FMT within the last 6 months. History of active diarrhea associated with inflammatory bowel disease (IBD). Major gastrointestinal surgery within the last 3 months before enrollment. Use of drugs that alter gut motility. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to enrollment. Unable or unwilling to undergo a colonoscopy Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy. Anticipated immediate or upcoming surgery within 30 days Need for continued non-anti-CDI antibiotic therapy History of total proctocolectomy Patients who are unable to give informed consent Participation in a clinical trial in the preceding 30 days or simultaneously during this trial Severe food allergy (anaphylaxis or anaphylactoid-like reaction) Life expectancy < 6 months Unable to adhere to protocol requirements Patient who have received an FMT in the past year Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT Clinically significant abnormal lab values including but not limited to WBC >15 x 103/mm3, ANC <0.5 x 103/mm3, or laboratory evidence of acute kidney injury at Investigator's discretion, at screening If a patient is heavily immunosuppressed and is negative for CMV or EBV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sari Feldman, MS
Phone
212-824-7669
Email
sari.feldman@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Grinspan, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sari Feldman, MS
Phone
212-824-7669
Email
sari.feldman@mssm.edu
First Name & Middle Initial & Last Name & Degree
Ari Grinspan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will not be shared with patients. However aggregate data will be shared with the NIH and for publications. The DSMB is within mount Sinai.

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MTC Versus FMT in for RCDI

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