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Compares treatment options for Clostridiodies Difficile Infections
Official title MTC Versus FMT in for RCDI
ClinicalTrials.gov ID: NCT05911997
What this study is testing
What is MTC 01?
MTC 01 is an investigational medicine, being studied as a potential treatment for clostridiodies difficile infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Investigating four different treatment of MTC or FMT
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
- people 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
You likely can't join if
- Female people 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...
- Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment.
- people with active gastroenteritis due to infectious causes other than CDI
- people with allergies to ingredients present in the investigational product
See the full eligibility 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)
- people 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.
- Female people 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...
- Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment.
- people with active gastroenteritis due to infectious causes other than CDI
- people 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.