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Microbiome Therapy
Fecal Microbiome Transfer vs. Vancomycin for C. difficile Infection (DONATE Trial)
N/A
Recruiting
Research Sponsored by Rambam Health Care Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days and 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if lyophilized fecal microbiome transfer can help reduce CDI symptoms & recurrence better than antibiotics. Participants get vancomycin plus capsules or vancomycin only, & stool samples & questionnaires.
Who is the study for?
Adults over 18 with a first-time, non-life-threatening Clostridioides difficile infection (CDI) confirmed by lab tests can join. They must be able to swallow pills and not have had CDI in the last 6 months or other diarrhea-causing infections, severe immune deficiencies, recent major gut surgery, life expectancy under 3 months, or certain allergies.
What is being tested?
The trial is testing if lyophilized fecal microbiome transfer (dried healthy donor stool bacteria) plus vancomycin is more effective than just vancomycin for treating primary CDI. Participants are split into two groups: one gets both treatments while the control group only receives vancomycin.
What are the potential side effects?
Potential side effects may include digestive discomfort from the fecal transplant capsules and typical antibiotic-related issues like stomach upset from vancomycin. The study will monitor changes in gut bacteria which could affect drug resistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days and 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CDI recurrence
Secondary study objectives
CDI recurrence in patients who achieved clinical cure
Clinical cure
Patient preference for treatment
+3 moreOther study objectives
Acquisition of multidrug-resistant organisms carriage
Changes in intestinal resistome
Shifts in the microbial community
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lyophilized fecal microbiome transfer (Lyo-FMT)Experimental Treatment1 Intervention
Vancomycin will be given orally in 125 mg capsules/solution 4 times daily for a total of 5 days (day 1 - initiation of therapy by the clinical team), followed by a loading dose of oral Lyo-FMT capsules on day 6 (15 capsules). On days 7-10, patients will receive 10 Lyo-FMT capsules per day. A total of 55 capsules, derived from \~30-40g of the original material, will be administered throughout 5 days. Prior to each Lyo-FMT administration, patients will be asked to fast for 8 hours. Bowel preparation or proton pump inhibitor use will not be required per protocol. The loading dose will be administered under medical supervision, while further dosing can be administered at the patient's home/institute, after training and guidance
Group II: Vancomycin monotherapyActive Control1 Intervention
Vancomycin will be given orally in 125 mg capsules/solution 4 times daily for a total of 10 days (day 1 - initiation of therapy by the clinical team, not from randomization).
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Who is running the clinical trial?
Rambam Health Care CampusLead Sponsor
512 Previous Clinical Trials
350,051 Total Patients Enrolled
Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER
667 Previous Clinical Trials
1,010,374 Total Patients Enrolled
European Institute of OncologyOTHER
152 Previous Clinical Trials
85,505 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot swallow.I was enrolled in the study within 4 days of starting CDI treatment.I am in the ICU with a severe infection not improving despite treatment.I had a C. diff infection within the last 6 months.I have been diagnosed with a chronic condition like IBS that causes long-term diarrhea.My stool test for C. difficile is positive, confirming an active infection.I can give informed consent or have a legal guardian who can.I am on antibiotics for a reason other than my trial condition and can stop them 1 day before the trial starts.I am currently experiencing GVHD in my digestive system.I have had my entire colon removed or I have a stoma.I am willing and able to follow the study rules, take pills, and give blood or stool samples as needed.My condition ranges from mild to severe.I have severe CDI with symptoms like very high fever, low blood pressure, or severe dehydration.I have had diarrhea and a positive test for C. difficile for the first time in 6 months.I have not had a perforated intestine, intestinal fistula, or major abdominal surgery in the last 30 days.I am 18 or older with a primary C. diff infection that is not severe.
Research Study Groups:
This trial has the following groups:- Group 1: Lyophilized fecal microbiome transfer (Lyo-FMT)
- Group 2: Vancomycin monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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