Recurrent Clostridium Difficile InfectionPhase 3NCT05201079

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

A Phase 3 study testing MBK-01 and Fidaxomicin in people with Recurrent Clostridium Difficile Infection and Primary Clostridium Difficile Infection, run by Mikrobiomik Healthcare Company S.L. at 21 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
What is being tested?: MBK-01 and Fidaxomicin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 21 sitesSpain
Study dates: 29 Oct 2021to 15 Nov 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Spain21 sites

Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario de Cruces
Barakaldo, 48903
Hospital Quirónsalud Barcelona
Barcelona, 08023
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital Universitario de Basurto
Bilbao, 48013
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014
Hospital Josep Trueta de Gerona
Girona, 17007
Hospital San Pedro
Logroño, 26006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Puerta de Hierro
Madrid, 28222
Hospital Universitario Quirónsalud Madrid
Madrid, 28223
Hospital Universitario Son Espases
Palma de Mallorca, 07120
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Hospital Universitario de Araba
Vitoria-Gasteiz, 01009
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009

Other trials in Spain

About this study

Official title: A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin.

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.

Read the detailed description

This is a Phase III, multicenter, controlled and open label clinical trial in which patients who suffered an episode of Clostridioides difficile infection (either the first episode or subsequent recurrences) will be randomly assigned (1:1) to one of the following arms:

Fidaxomicin
MBK-01 (heterologous lyophilized fecal microbiota)

Objective: To assess the efficacy of FMT with capsules of lyophilized fecal microbiota (MBK-01), compared to the control (fidaxomicin) at 8 weeks after the start of the treatment. Also, assess the safety of MBK-01 and the quality of life of patients participating in the study.

Follow up: participants will return for clinic visits at 72 hours, week 3 and week 8 after the start of the treatment, and will receive follow-up phone calls at month 3 and month 6 after the start of the treatment. Stool samples will be collected from participants for further studies at time 0 and week 8 after the start of the treatment. Study Outcomes are detailed in the specific section of this website.

Rationale: The transferred microbiota restores the recipient's intestinal microbiota by reintroducing bacterial taxa that were absent or in low proportion in the recipient before the FMT. This supports the expansion of the recipient's own commensal microbiota and re-establishing a microbiota community with a high biodiversity.

Donors: All donors are screened to ensure they meet the strict requirements necessary to maintain the safety of the MBK-01.

Justification: The treatment of Clostridioides difficile infections (CDI) with antibiotics is usually effective for acute symptoms, but after the initial treatment, the probability of recurrence at 8 weeks ranges from 10-20 % of cases, and once a patient has a recurrence, the probability of further recurrences increases up to 40-65 %. In recent 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. 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, with recurrences occurring in up to 30-40% of patients. Furthermore, antibiotic treatment does not correct deficiencies in the intestinal microbiota that facilitate CD infection and is associated with the risk of the emergence of antibiotic-resistant bacteria. Moreover, the treatment of recurrences is not adequately standardized. In recent years, although the most widely used alternatives have been fidaxomicin and bezlotoxumab, their efficacy in patients who already suffer from r-CDI is not proven. The administration of the FMT through oral capsules, although it is not standardized, has proven to be effective in the restoration of intestinal microbiota of patients with r-CDI. In addition, the use of lyophilized formulas facilitates the concentration of bacteria and further optimizes the donors' sample and reduces the amount of capsules that the patient has to ingest.

Conditions: Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Being tested: MBK-01, Fidaxomicin
Keywords: Clostridium difficile, FMT, Fecal Microbiota Transfer
Medical subject headings: Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MBK-01Biological
Also called Fecal microbiota transfer
A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
FidaxomicinDrug
Also called Dificlir, Dificid
Oral administration of 200mg/12 hours of fidaxomicin for 10 days.

Study groups in NCT05201079
Study group	Role	What they receive
MBK-01	Experimental	Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients). Receives: Biological: MBK-01
Fidaxomicin	Active comparator	Participants will receive Fidaxomicin (47 patients). Receives: Drug: Fidaxomicin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after the start of the treatment

Secondary outcomes (16)

Duration of Hospitalisation
Time, in days, that the patient remains in the hospital as a result of CDI (but not necessarily indicating a recurrence of diarrhea due to CDI).
Measured: Up to 8 weeks after the start of the treatment
Good/Bad Progress of the Patient
A bad progress of the patient is defined as the detection 48-72 hours after the start of the treatment (MBK-01 or Fidaxomicin) of:
A worsening of the diarrhea episode (at least one stool more than at baseline, baseline being understood as the time of the start of the study treatment (fidaxomicin or MBK01)).
And, at least, one of the following factors:
- Increase in C-reactive protein (CRP) value (> 5 % of the baseline value).
- Increase in white blood cell count (> 5 % of the baseline value).
- Progression to sepsis: hypotension or organ failure with no other apparent cause.
Measured: Up to 72 hours after the start of the treatment
Time to Recurrence Depending on Randomisation Groups
Recurrence: Reappearance of clinical manifestations of a new CDI episode in a patient with an CDI episode treated and cured in the previous 8 weeks.
Measured: Up to 6 months after the start of the treatment
Duration of Treatment
Duration in days of the treatment.
Measured: Up to 10 days
Overall Survival
Percentage of patients that are still alive after a defined period of time from the beginning of the treatment.
Measured: Up to 6 months after the start of the treatment
Number of Adverse Events Per Randomisation Group
Number of Adverse Events per randomisation group since baseline.
Measured: Up to 6 months after the start of the treatment
Type of Adverse Events Per Ramdomisation Group
Type of Adverse Events per ramdomisation group since baseline.
Measured: Up to 6 months after the start of the treatment
Number of Serious Adverse Events Per Ramdomisation Group
Number of Serious Adverse Events per ramdomisation group since baseline.
Measured: Up to 6 months after the start of the treatment
Type of Serious Adverse Events Per Ramdomisation Group
Type of Serious Adverse Events per ramdomisation group since baseline.
Measured: Up to 6 months after the start of the treatment
Adverse Events Related to the Treatment
Adverse Events related to the treatment since baseline.
Measured: Up to 6 months after the start of the treatment
Adverse Event Seriousness
Adverse Event Seriousness since baseline.
Measured: Up to 6 months after the start of the treatment
Adverse Events Related to the CDI
Adverse Events related to the CDI since baseline.
Measured: Up to 6 months after the start of the treatment
Mortality Associated With CDI
Percentage of patients that die due to CDI after a defined period of time from the beginning of the treatment.
Measured: Up to 6 months after the start of the treatment
Intensive Care Unit Admissions (ICU)
Percentage of patients admitted in the ICU after a defined period of time from the beginning of the treatment.
Measured: Up to 6 months after the start of the treatment
Adverse Events of Special Interest
Adverse Events of special interest since baseline.
Measured: Up to 6 months after the start of the treatment
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status).
Measured: Day 0, 8 weeks and 6 months after the start of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202115 Nov 2023

First posted21 Jan 2022
Study start29 Oct 2021
Primary completion15 Nov 2023
Study completion15 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Recurrent Clostridium Difficile InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05201079
Sponsor's protocol ID: ICD-01
Other IDs: 2020-004591-17
Status last verified: Mar 2025
First submitted: 14 Dec 2021
Last updated: 25 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 31883938
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.
PubMed 30221898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection
RecruitingPhase 1/2
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Clostridioides Difficile Infection, Recurrent Infection
RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence

All Recurrent Clostridium Difficile Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin.
ClinicalTrials.gov ID: NCT05201079
Acronym / sponsor ID: ICD-01
Conditions: Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Keywords: Clostridium difficile, FMT, Fecal Microbiota Transfer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Mikrobiomik Healthcare Company S.L.Industry (pharma, biotech, devices)
Study start: 29 Oct 2021 (actual)
Primary completion: 15 Nov 2023 (actual)
Study completion: 15 Nov 2023 (actual)
First posted: 21 Jan 2022 (actual)
Results: Posted 25 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Fidaxomicin
MBK-01 (heterologous lyophilized fecal microbiota)

Donors: All donors are screened to ensure they meet the strict requirements necessary to maintain the safety of the MBK-01.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MBK-01	Experimental	Biological: MBK-01Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
Fidaxomicin	Active comparator	Drug: FidaxomicinParticipants will receive Fidaxomicin (47 patients).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (9 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MBK-01Also: Fecal microbiota transferA single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.	Biological	MBK-01
FidaxomicinAlso: Dificlir, DificidOral administration of 200mg/12 hours of fidaxomicin for 10 days.	Drug	Fidaxomicin

Primary outcome

Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment
Time frame: 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.
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment
Time frame: 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.
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment
Time frame: 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.
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment
Time frame: 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.
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment
Time frame: 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.

16 secondary outcomes

Duration of Hospitalisation
Time frame: Up to 8 weeks after the start of the treatment
Good/Bad Progress of the Patient
Time frame: Up to 72 hours after the start of the treatment
Time to Recurrence Depending on Randomisation Groups
Time frame: Up to 6 months after the start of the treatment
Duration of Treatment
Time frame: Up to 10 days
Overall Survival
Time frame: Up to 6 months after the start of the treatment
Number of Adverse Events Per Randomisation Group
Time frame: Up to 6 months after the start of the treatment
Type of Adverse Events Per Ramdomisation Group
Time frame: Up to 6 months after the start of the treatment
Number of Serious Adverse Events Per Ramdomisation Group
Time frame: Up to 6 months after the start of the treatment
Type of Serious Adverse Events Per Ramdomisation Group
Time frame: Up to 6 months after the start of the treatment
Adverse Events Related to the Treatment
Time frame: Up to 6 months after the start of the treatment
Adverse Event Seriousness
Time frame: Up to 6 months after the start of the treatment
Adverse Events Related to the CDI
Time frame: Up to 6 months after the start of the treatment
Mortality Associated With CDI
Time frame: Up to 6 months after the start of the treatment
Intensive Care Unit Admissions (ICU)
Time frame: Up to 6 months after the start of the treatment
Adverse Events of Special Interest
Time frame: Up to 6 months after the start of the treatment
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Time frame: Day 0, 8 weeks and 6 months after the start of the treatment

Results and safety

Results posted to the registry on 25 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MBK-01	45	23
Fidaxomicin	47	25

Primary outcome: Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment

Time frame: 8 weeks after the start of the treatment. Count of participants. Unit: Participants

Measure	MBK-01 n = 37	Fidaxomicin n = 40
Value	4	9

MBK-01 vs Fidaxomicin: Odds Ratio (OR): 2.395 (97.79% CI 0.540 to 10.624), p = 0.228, Regression, Logistic

Population analysed: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.

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

Time frame: 72 hours after the start of the treatment. Count of participants. Unit: Participants

Measure	MBK-01 n = 37	Fidaxomicin n = 40
Value	1	0

Population analysed: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.

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

Time frame: 3 weeks after the start of the treatment. Count of participants. Unit: Participants

Measure	MBK-01 n = 37	Fidaxomicin n = 40
Value	2	2

Population analysed: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.

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

Time frame: 3 months after the start of the treatment. Count of participants. Unit: Participants

Measure	MBK-01 n = 37	Fidaxomicin n = 40
Value	4	9

Population analysed: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months after the start of the treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MBK-01	9 of 45 (20%)	36 of 45 (80%)	1 of 45
Fidaxomicin	4 of 47 (8.5%)	38 of 47 (80.9%)	1 of 47

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31883938Reigadas 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.
Background: PubMed 30221898Reigadas 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.
EU Clinical Trials RegisterLink provided by the sponsor.

Related trials for Recurrent Clostridium Difficile Infection

Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection
RecruitingPhase 1/2
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Clostridioides Difficile Infection, Recurrent Infection
RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier Cobo, MD principal investigator

Hospital Universitario Ramon y Cajal

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment (time frame: 8 weeks after the start of the treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201079, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.