BridgeMD
New treatment option for Clostridioides Difficile Infection
Official title Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
ClinicalTrials.gov ID: NCT05266807
What this study is testing
What is oral capsulized Fecal Microbiota Transplantation?
oral capsulized Fecal Microbiota Transplantation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for clostridioides difficile infection.
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
- The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioides difficile infection (CDI). Experimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days) followed by FMT by oral capsules (one FMT, i.e.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Adults (≥18 years old) at the time of informed consent
- Informed consent signature
- Medical record documentation of CDI defined as: a. A first CDI episode associated with risks factors for recurrence, defined as: i. No CDI episode...
- age \>65 years-old,
- hospitalization within the last 3 months,
You likely can't join if
- Severe-complicated CDI if at least one of the following signs or symptoms are:
- ongoing at time of screening and related to CDI: hypotension, septic shock, elevated serum lactate, ileus,
- or were present at any time of the CDI episode and related to CDI: toxic megacolon, bowel perforation, or any fulminant course of disease (i.e. rapid...
- Prior FMT within 6 months of randomization,
- Prior total colectomy, colostomy, ileostomy, or gastrectomy
- Metronidazole already given alone for the treatment of the current CDI for more than 3 days,
See the full eligibility criteria
- Adults (≥18 years old) at the time of informed consent
- Informed consent signature
- Medical record documentation of CDI defined as: a. A first CDI episode associated with risks factors for recurrence, defined as: i. No CDI episode within the last 8 weeks ii. Current combination of CDI signs and...
- age \>65 years-old,
- hospitalization within the last 3 months,
- use of proton pump inhibitors (PPI) within the last 3 months,
- Charlson comorbidity index (CCI) \>2,
- living in long term facility,
- healthcare- associated CDI (see definition in section 7),
- severe CDI episode (see definitions in section 6.1.2),
- immunocompromised patient (except severely immunocompromised according to definitions in section 7.1),
- history of prior CDI episode(s) (more than 8 weeks ago). OR b. A first CDI recurrence, defined as: i. Previous episode of treated and cured CDI within the last 8 weeks confirmed by medical record documentation of a...
- No multiple episodes (no more than 2 CDI episodes) within 3 last months.
- Already taking since less than 10 days or will start a course of antibiotics (vancomycin or fidaxomicin) to control recurrent CDI symptoms at the time of screening.
- Willing and able to have FMT by capsule
- Severe-complicated CDI if at least one of the following signs or symptoms are:
- ongoing at time of screening and related to CDI: hypotension, septic shock, elevated serum lactate, ileus,
- or were present at any time of the CDI episode and related to CDI: toxic megacolon, bowel perforation, or any fulminant course of disease (i.e. rapid deterioration of the patient.
- Prior FMT within 6 months of randomization,
- Prior total colectomy, colostomy, ileostomy, or gastrectomy
- Metronidazole already given alone for the treatment of the current CDI for more than 3 days,
- Need for continued non-anti-CDI systemic antibiotics (should be stopped at randomization at the latest), except prophylactic doses of trimethoprim/sulfamethoxazole,
- Anticipated indication for antibiotics treatment (for a non-CDI reason) in the next 8 weeks except prophylactic doses of trimethoprim/sulfamethoxazole
- Other causes of chronic or acute diarrhea beyond CDI (chronic diarrhea is defined as loose/watery stools, which occur three or more times within 24 hours and last for 4 or more weeks)
- Inflammatory bowel disease,
- Patients with swallowing disorders, Zenker's diverticulum, gastroparesis, or prior small bowel obstruction,
- Known hypersensitivity to vancomycin or fidaxomicin,
- Pregnant/lactating women,
- Estimated patient's life expectancy of less than 10 weeks,
- Inability to follow protocol study procedures,
- Inability to give informed consent,
- Any condition or medications that will put the participant at greater risk from FMT according to the investigator,
- Severely immunocompromised
- No response to anti-CDI antibiotic treatment after at least 5 days of treatment (i.e. no diminution of the daily number of stools at BSS 6-7 compared to first day of treatment; or worsening of CDI severity parameters)
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Basel, Switzerland
- Bern, Canton of Bern, Switzerland
- Fribourg, Canton of Fribourg, Switzerland
- Lucerne, Canton of Lucerne, Switzerland
- Sankt Gallen, Canton of St. Gallen, Switzerland
- Lausanne, Canton of Vaud, Switzerland
- Zurich, Canton of Zurich, Switzerland
- Sion, Valais, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Basel, Basel, Switzerland; Bern, Canton of Bern, Switzerland; Fribourg, Canton of Fribourg, Switzerland; Lucerne, Canton of Lucerne, Switzerland; Sankt Gallen, Canton of St. Gallen, Switzerland; Lausanne, Canton of Vaud, Switzerland and 2 more location(s). 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.