STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection

Launched by MEDICAL UNIVERSITY OF WARSAW · Aug 6, 2025

Keywords

ClinConnect Summary

This clinical trial, called STOP-CDI, is studying the best way to treat and prevent the return of a common and sometimes serious infection called Clostridioides difficile infection (CDI). CDI often causes diarrhea and can come back after treatment, especially in older adults or people with other health problems. The study is comparing three treatments: a standard antibiotic called vancomycin, another antibiotic called fidaxomicin, and a newer approach called fecal microbiota transplantation (FMT), where healthy bacteria from donated stool are given to help restore the gut’s natural balance. The goal is to see which method works best to stop the infection from coming back within 12 weeks.

People who might join this study include adults aged 65 or older, or younger adults with certain health risks like previous CDI infections, recent hospital stays, or the use of other antibiotics or stomach acid medicines. Participants will be randomly assigned to one of the three treatments and will be closely monitored to see how well the infection is cured and if it returns. The FMT treatment is given as capsules or, if needed, through other medical procedures. This study is important because it will help doctors understand which treatments work best in real-life settings, especially where newer medicines are hard to get. Participants can expect careful medical follow-up and contribute to research that may improve care for many people with CDI in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Individuals aged 65 years or older OR individuals aged 18 to 64 years who meet at least one of the following criteria:
• • Presence of at least two comorbid chronic diseases from the groups of cardiovascular diseases, respiratory system diseases, gastrointestinal diseases, autoimmune diseases, cancers, chronic kidney and genitourinary diseases, immunodeficiencies, diabetes, and metabolic diseases,
• • Previous episodes of CDI,
• • Healthcare-associated CDI and/or hospitalization within the last three months,
• • Concurrent use of antibiotics other than CDI treatment after CDI diagnosis,
• • Use of proton pump inhibitors (PPIs) started during or after CDI diagnosis.
• * Documented Clostridioides difficile infection, defined according to ESCMID as:
• Diagnosis of diarrhea associated with C. difficile defined by:
• • \> 3 unformed stools (or \>200 ml of unformed stool in patients with stool collection devices) within 24 hours before randomization AND
• • Clinical signs consistent with CDI and microbiological evidence of free C. difficile toxins in an enzyme immunoassay (EIA) without justified evidence of another cause of diarrhea OR
• • Clinical picture consistent with CDI and positive nucleic acid amplification test (NAAT; PCR) preferably with low cycle threshold (Ct) value, or positive toxigenic C. difficile culture OR
• • Pseudomembranous colitis diagnosed during endoscopy or colectomy combined with a positive test for toxigenic C. difficile.
• • No more than 24 hours of prior treatment with vancomycin, metronidazole, or fidaxomicin.
• • Absolute neutrophil count in peripheral blood within 3 days before intervention \> 500/µl.
• • Ability to swallow large capsules (using test capsules) or no contraindications for FMT via nasojejunal tube, gastroscopy, colonoscopy, or rectal enema.
• • Provided informed consent for participation in the clinical study.
• Exclusion Criteria:
• • Lack of consent to participate in the study or absence of logical contact without possibility of obtaining consent from an authorized person,
• • More than 24 hours of prior treatment with vancomycin, metronidazole, or fidaxomicin,
• • On the day of inclusion (up to 3 days before starting intervention) absolute neutrophil count in blood \<500 cells/µl or expected drop to this level within the next 2 days,
• • Diagnosed HIV infection with CD4 lymphocyte count \<250 cells/µl,
• • Inability to swallow large capsules (failed test capsule use) or contraindications for FMT via upper or lower gastrointestinal tract, including gastrointestinal perforation, anal atresia, discontinuity of the gastrointestinal tract, and others,
• • Known presence of other pathogens in stool known to cause diarrhea,
• • Life expectancy \<3 months,
• • Life-threatening CDI (fulminant at diagnosis - especially with septic shock),
• • Total or subtotal colectomy, ileostomy, or colostomy,
• • Unwillingness or inability to comply with protocol requirements, including any condition (physical, mental, or social) that may affect the participant's ability to adhere to the protocol.