BridgeMD
Evaluation of EXL01 a new Live Biotherapeutic Product to prevent recurrence of Clostridioides difficile infection in high-risk patients. LIVEDIFF
EU CTIS ID: 2023-506232-32-00
What this study is testing
Phase I: Evaluation of the safety and tolerability of oral EXL01 Phase II: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection at S8 in patients at high risk of recurrence
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient over 18 years of age
- 3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stools by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI or 2nd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stool by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI with at least one of the following risk factors: - Age ≥70 years - Chronic renal failure (haemodialysis or GFR<60ml/min) - History of severe or severe-complicated CDI (excluding current episode) according to ESCMID 2021 criteria - ≥3 episodes of CDI in the last 12 months (including the current episode) - Care-associated CDI defined as CDI occurring during hospitalisation (<3 months)
- On current or planned vancomycin treatment per os
- Patient capable of giving free, informed and written consent
- Enrolled in the national compulsory social security scheme
You likely can't join if
- Currently participating or has participated in a study with an investigational compound or device in the 3 months prior to the first dose of the study intervention.
- Surgery scheduled during the study requiring perioperative antibiotics.
- Antibiotic treatment in progress or planned during the study for an infection other than CDI
- History of chronic diarrhoea (> 3 liquid stools per day for > 4 weeks) not related to a gastrointestinal infection.
- Clinically significant medical or surgical condition not mentioned in the above criteria which, in the opinion of the investigator, could interfere with the administration of the study drug, the interpretation of the study safety or efficacy data, or compromise the safety or well-being of the subject.
- Women without contraception, pregnant or breast-feeding women
See the full eligibility criteria
Who can join
- Patient over 18 years of age
- 3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stools by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI or 2nd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stool by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI with at least one of the following risk factors: - Age ≥70 years - Chronic renal failure (haemodialysis or GFR<60ml/min) - History of severe or severe-complicated CDI (excluding current episode) according to ESCMID 2021 criteria - ≥3 episodes of CDI in the last 12 months (including the current episode) - Care-associated CDI defined as CDI occurring during hospitalisation (<3 months)
- On current or planned vancomycin treatment per os
- Patient capable of giving free, informed and written consent
- Enrolled in the national compulsory social security scheme
What rules you out
- Currently participating or has participated in a study with an investigational compound or device in the 3 months prior to the first dose of the study intervention.
- Surgery scheduled during the study requiring perioperative antibiotics.
- Antibiotic treatment in progress or planned during the study for an infection other than CDI
- History of chronic diarrhoea (> 3 liquid stools per day for > 4 weeks) not related to a gastrointestinal infection.
- Clinically significant medical or surgical condition not mentioned in the above criteria which, in the opinion of the investigator, could interfere with the administration of the study drug, the interpretation of the study safety or efficacy data, or compromise the safety or well-being of the subject.
- Women without contraception, pregnant or breast-feeding women
- History of hypersensitivity to EXL01 and/or to any excipient with a known effect (D-mannitol, sucrose, maltodextrin, L-cysteine, L-cysteine hydrochloride, magnesium stearate and hydroxypropylmethylcellulose), and/or soya or products containing soya.
- History of hypersensitivity to vancomycin mentioned in the local prescribing information.
- Personal history of faecal microbiota transplantation < 6 months.
- Participation in another interventional studY. (Patients who have entered the follow-up phase of an interventional study may participate provided that more than 3 months have elapsed since the last intervention.)
- Person deprived of liberty by a judicial or administrative decision
- Chronic inflammatory bowel disease
- Adults subject to a legal protection measure or unable to express their consent
- Refractory C. difficile infection defined as lack of response to adequate treatment with oral vancomycin or fidaxomicin with ≥3 liquid stools per day after ≥5 days of treatment
- Severe C. difficile infection severe (defined by the presence of a white blood cell count >15×10⁹ cells/L or a body temperature >38.5°C or >50% increase in the patient's baseline creatinine related to CDI at the time of V1) and/or complicated (defined by any of the factors attributed to current Clostridioides difficile infection (CDI): hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, intestinal perforation or any fulminant course of the disease) Translated with DeepL.com (free version)
- Expected life expectancy of less than 6 months
- Presents a known psychiatric disorder that would interfere with adequate cooperation with the study requirements.
- Regular use of illicit or recreational drugs that may interfere with medication administration or data interpretation
- Cirrhosis with Child C score
- Personal history of gastrointestinal resection resulting in chronic diarrhea (>3 loose stools per day)
- Personal history of microbial overgrowth of the small intestine
- Hospitalisation in a continuing care unit or intensive care unit
- Proven uncontrolled celiac disease
- Current stoma (ileostomy or colostomy) or within the last 6 months or any other intra-abdominal surgery within the 3 months prior to treatment
- Swallowing disorders making it impossible to take oral treatment
- major surgery or trauma ≤ 4 weeks before the start of treatment or if > 4 weeks with an unresolved healing process that could affect the assessment or safety of the study treatment.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.