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

NCT05201079 | Completed Phase 3 Results

• 2 other identifiers: ICD-012020-004591-17
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Recurrent Clostridium Difficile Infection; Primary Clostridium Difficile Infection

Keywords

Clostridium difficile; FMT; Fecal Microbiota Transfer

Outcome Measures

Primary Outcomes (5)

• Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment

  Number of patients who showed recurrence of at least one Episode of Diarrhea (3 or More Stools/24 Hours) 8 Weeks After the Start of the Treatment. Recurrence is understood as the reappearance of clinical manifestations of a new episode of CDI that re-occurs within 8 weeks after the onset of symptoms of a previous episode that was resolved.

  8 weeks after the start of the treatment

• Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment

  Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.

  72 hours after the start of the treatment

• Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment

  Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.

  3 weeks after the start of the treatment

• Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment

  Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.

  3 months after the start of the treatment

• Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment

  Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.

  6 months after the start of the treatment

Secondary Outcomes (16)

• Duration of Hospitalisation

  Up to 8 weeks after the start of the treatment

• Good/Bad Progress of the Patient

  Up to 72 hours after the start of the treatment

• Time to Recurrence Depending on Randomisation Groups

  Up to 6 months after the start of the treatment

• Duration of Treatment

  Up to 10 days

• Overall Survival

  Up to 6 months after the start of the treatment

Study Arms (2)

MBK-01

EXPERIMENTAL

Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).

Biological: MBK-01

Fidaxomicin

ACTIVE COMPARATOR

Participants will receive Fidaxomicin (47 patients).

Drug: Fidaxomicin

Interventions

MBK-01 BIOLOGICAL

A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.

Also known as: Fecal microbiota transfer

MBK-01

Fidaxomicin DRUG

Oral administration of 200mg/12 hours of fidaxomicin for 10 days.

Also known as: Dificlir, Dificid

Fidaxomicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 \<500 cells /μL at the time of the enrollment in the study.
• Pregnancy, breastfeeding, or pregnancy intentions over the course of the study.
• Active treatment with bile acid sequestrants (for instance: cholestyramine).
• Positive patients for the human immunodeficiency virus (HIV) except those with lymphocytes T CD4 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.

Sponsors & Collaborators

• Mikrobiomik Healthcare Company S.L.: lead

Study Sites (21)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

Location

Hospital Quirónsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario de Basurto

Bilbao, 48013, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, 20014, Spain

Location

Hospital Josep Trueta de Gerona

Girona, 17007, Spain

Location

Hospital San Pedro

Logroño, 26006, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

Location

Hospital Universitario Quirónsalud Madrid

Madrid, 28223, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Hospital Universitario de Araba

Vitoria-Gasteiz, 01009, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (2)

• Reigadas E, Bouza E, Olmedo M, Vazquez-Cuesta S, Villar-Gomara L, Alcala L, Marin M, Rodriguez-Fernandez S, Valerio M, Munoz P. Faecal microbiota transplantation for recurrent Clostridioides difficile infection: experience with lyophilized oral capsules. J Hosp Infect. 2020 Jun;105(2):319-324. doi: 10.1016/j.jhin.2019.12.022. Epub 2019 Dec 26.

  PMID: 31883938 BACKGROUND

• Reigadas E, Olmedo M, Valerio M, Vazquez-Cuesta S, Alcala L, Marin M, Munoz P, Bouza E. Fecal microbiota transplantation for recurrent Clostridium difficile infection: Experience, protocol, and results. Rev Esp Quimioter. 2018 Oct;31(5):411-418. Epub 2018 Sep 14.

  PMID: 30221898 BACKGROUND

Related Links

• EU Clinical Trials Register

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation; Fidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

The statistical power of the study was limited due to the small sample size, which may have prevented finding statistically significant differences between MBK-01 and fidaxomicin. Additionally, the lack of available comparative studies between FMT and fidaxomicin in primary episodes of CDI in the literature limits the ability to contextualize our findings.

Results Point of Contact

• Title: Olaia Aurtenetxe Saez
• Organization: Mikrobiomik Healthcare Company S.L.

ensayosclinicos@mikrobiomik.net

+34 944 540 166

Study Officials

• Javier Cobo, MD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 21, 2022
• Study Start: October 29, 2021
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Locations

ES (21)