Phase 3 N=92 Randomized Treatment

Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin

Recurrent Clostridium Difficile Infection · Primary Clostridium Difficile Infection

Bottom Line

View on ClinicalTrials.gov: NCT05201079 ↗

Enrolled (actual)

Serious AEs

14.1%

Results posted

Mar 2025

Primary outcome: Primary: Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment — 4; 9 Participants — p=0.228

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MBK-01 (Biological); Fidaxomicin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mikrobiomik Healthcare Company S.L.
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment	4; 9	0.228
PRIMARY Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment	1; 0	—
PRIMARY Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment	2; 2	—
PRIMARY Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment	4; 9	—
PRIMARY Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment	4; 9	—
SECONDARY Duration of Hospitalisation	6.50; 5.50	—
SECONDARY Good/Bad Progress of the Patient	43; 44; 0; 1; 2; 1	—
SECONDARY Time to Recurrence Depending on Randomisation Groups	24.70; 22.40	0.300
SECONDARY Duration of Treatment	1.0; 10.0	—
SECONDARY Overall Survival	44; 46	0.900
SECONDARY Number of Adverse Events Per Randomisation Group	89; 103	—
SECONDARY Type of Adverse Events Per Ramdomisation Group	1; 0; 0; 1; 1; 0	—
SECONDARY Number of Serious Adverse Events Per Ramdomisation Group	11; 5	—
SECONDARY Type of Serious Adverse Events Per Ramdomisation Group	1; 0; 1; 0; 0; 1	—
SECONDARY Adverse Events Related to the Treatment	1; 3	—
SECONDARY Adverse Event Seriousness	70; 77; 17; 22; 1; 4	—
SECONDARY Adverse Events Related to the CDI	0; 1; 17; 28; 3; 4	—
SECONDARY Mortality Associated With CDI	0; 0	—
SECONDARY Intensive Care Unit Admissions (ICU)	0; 0	—
SECONDARY Adverse Events of Special Interest	4; 2; 1; 0; 3; 2	—
SECONDARY SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life	56.9; 57.07; 68.5; 62.58; 77.5; 77.73	0.749

Summary

Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI). The incidence and severity of CDI has increased in recent years and CDI recurrences (r-CDI) due to the appearance of new episodes in patients with a previous cured CDI, represent a serious and complex clinical issue. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure. In addition, the treatment of r-CDI is not adequately standardized, and although the most widely used treatment is the administration of fidaxomicin and bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In the late years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. The objective of this study is to assess the efficacy and safety of the MBK-01 medication, consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors in comparison to the treatment with fidaxomicin, in 92 patients with primary or r-CDI.

Eligibility Criteria

Inclusion Criteria

Patients of both genders, over 18 years.
Patients that undergo an episode of CD infection (either the first episode or subsequent recurrences).
Presence of an episode of diarrhea defined as ≥3 stools/24 hours, at the beginning of the episode.
Confirmation of the presence of CD toxin A and/or B in faeces, by a direct toxin detection test or by the PCR technique for the detection of toxin/s producing genes, at the start of the episode that is going to be treated in the clinical trial (the toxin test must be positive within 7 days prior to the enrolment of the patient in the trial).

Exclusion Criteria

Previous faecal microbiota transfer.
Transplanted patients, except those with a solid organ transplant of more than 2 years, with good organ function.
Absolute neutrophil count 200 cells/μL and viral load less than 20 copies.
Swallowing dysfunction or no oral motor coordination.
Patient admitted in an intensive care unit or expected to be admitted in an intensive care unit due to serious illness.
History of significant medical conditions that, in the opinion of the investigator, would not allow an adequate evaluation or follow-up of the patient.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05201079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.