EUTEGRA

Restores the

gut microbiota

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Mikrobiomik is a Basque biotechnology company with a clear mission: to be the first in Spain to bring a gut microbiota-based therapy to patients with unmet medical needs.

Fecal Microbiota Transplan (FMT)

Therapies based on gut microbiota aim to restore the balance of the microbial ecosystem by transferring microbiota from healthy, rigorously selected donors.

Fecal Microbiota Transplan (FMT) are now endorsed by leading international clinical guidelines — including ESCMID and IDSA — as a recommended intervention for recurrent Clostridioides difficile infections.

Its mechanism of action, based on the ecological restoration of the microbiome, establishes a new therapeutic category with a profile of efficacy and safety supported by clinical evidence.

Therapy

EUTEGRA (MBK-01)

Over many years of clinical research, through the Phase III clinical trial and the compassionate use programme in more than 35 Spanish hospitals, we worked together with patients and healthcare professionals to build the evidence base that now supports EUTEGRA. What was then known as MBK-01 has evolved to become the first authorised gut microbiota biological therapy in Spain.

EUTEGRA is a full-spectrum gut microbiota biological therapy, developed using FSPIM (Full Spectrum & Purified Intestinal Microbiota) technology and manufactured following strict quality standards.

01

Presentation

Oral administration, with no invasive procedures.
A single course of treatment comprising 4 enteric-coated capsules, ready for integration into hospital clinical practice without the need for a colonoscopy or additional infrastructure.

02

Indication

Recurrent Clostridioides difficile Infection (rCDI).
Indicated as first-line treatment following failure or recurrence of standard antibiotic therapy; one of the leading causes of hospital-acquired infection in developed countries.

03

Clinical evaluation

Clinically evaluated against fidaxomicin.
Supported by the available data from the MBK-01 / EUTEGRA clinical development programme, including a Phase III trial and compassionate use in Spanish hospitals.

Trust based on clinical data

EUTEGRA, formerly MBK-01, has been evaluated in the ICD-01 clinical trial, a phase III, randomised, controlled, open-label study, compared with fidaxomicin.

Clinical trial ICD-01

Evaluation of freeze-dried faecal microbiota oral capsules in comparison with fidaxomicin in patients with primary or recurrent Clostridioides difficile infection.

  • Trial code: ICD-01
  • Patients enrolled: 92
  • 21 centres in Spain
  • 8 weeks. Primary endpoint: absence of recurrence

Compassionate Use Programme

130

Patients treated

36

Centres
  • País Vasco
  • Comunidad Valenciana
  • Madrid
  • Aragón
  • Castilla y León
  • Andalucía
  • Castilla -La Mancha
  • Asturias
  • La Rioja
  • Baleares
  • Canarias
Ver H. Princesa Sofía

Registration

NCT05201079

Study ID on ClinicalTrials.gov. The safety follow-up assessed adverse events for up to 6 months.

Links

FMT capsules (MBK-01) compared to fidaxomicin for the treatment of primary and recurrent CDI.

Preprint results ICD-01

Compassionate use experience with MKB-01 capsules in rCDI.

Microorganisms Article

Clinical use of EUTEGRA

EUTEGRA must always be assessed within the relevant clinical system and in accordance with its approved indication.

Healthcare professionals may contact Mikrobiomik for information on the access process, the documentation required and the applicable requirements.

Contact Mikrobiomik

For which patients is it indicated?

Patients with recurrent Clostridioides difficile infection, in accordance with the authorised indication and clinical judgement.

When should It be used?

When a healthcare professional considers gut microbiota-based therapy as part of the management of recurrence.

If you are a patient…

Consult your healthcare professional. EUTEGRA must not be requested directly by the patient. Its use requires professional assessment.

If you are a healthcare professional…

Eutegra is currently in the pre-launch phase and will soon be available in hospitals.

From donor to patient

Donor selection

Donors are evaluated using clinical criteria, medical questionnaires and analytical tests, in accordance with the AEMPS-ONT reference framework for fecal microbiota.

Rigorous quality system

Manufacturing, storage and final product release processes are governed by quality procedures.

Traceability

A documented system for tracking donations, preparation and clinical administration.

Clinical safety

Evaluated in the ICD-01 trial and in published hospital experience.

Authorised under the SoHO regulations

EUTEGRA has been authorised in Spain under the European framework for Substances of Human Origin (SoHO).

EUROPEAN FRAMEWORK

Traceability

Regulations on quality, safety, authorization, traceability and biovigilance applicable to substances of human origin intended for use in humans.

BENCHMARK ORGANISATION

ONT

The National Transplant Organisation is the reference organization in Spain working in the field of SoHO.
See the Spanish framework for substances of human origin.

Go to the ONT SoHO Area

NATIONAL CONSENSUS

AEMPS-ONT

Consensus document on the donation, collection, processing and transplantation of faecal microbiota for C. difficile infection.

Document

FAQ

The essentials about EUTEGRA: regulation, clinical use and safety assurances.

No. EUTEGRA is a biological therapy based on gut microbiota, regulated under SoHO regulations.

No. Its use must be assessed by a healthcare professional and managed within the appropriate hospital clinical system.

For the treatment of recurrent Clostridioides difficile infection (rCDI), in accordance with the authorised indication and medical criteria.

As a single dose of 4 enteric-coated capsules taken orally. It does not require any invasive procedures or a colonoscopy.

Rigorous donor selection and screening, standardised processing, analytical quality controls, full batch traceability and release of the encapsulated product in accordance with pharmaceutical standards.

Under the SoHO (Substances of Human Origin) regulatory standards, the European framework governing substances of human origin intended for therapeutic use.

Would you like to find out more about EUTEGRA?

Select the option that best describes your enquiry

Healthcare professional

Clinical information

View information on indications, clinical data, access procedures and applicable requirements.

Request medical information.

Email eutegra@mikrobiomik.net

Patient

Consult your doctor

If you have experienced recurrent Clostridioides difficile infections, discuss the available treatment options with your healthcare team. For any general enquiries, please contact Mikrobiomik.

Email hello@mikrobiomik.net

Legal notice / compliance

The information contained on this page is for informational purposes only and is not a substitute for the assessment, diagnosis or prescription of a healthcare professional. EUTEGRA must be used in accordance with its authorised indication, medical judgement and applicable clinical pathways. Data from preprints should be interpreted bearing in mind that they have not yet completed the peer-review process.

References

  1. Cobo J, et al. FMT capsules (MBK-01) compared to fidaxomicin for the treatment of primary and recurrent Clostridioides difficile infection. Research Square.
  2. ClinicalTrials.gov: NCT05201079. ICD-01.
  3. Cano A, et al. Compassionate Use of Encapsulated MKB-01 Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection. Microorganisms. 2025;13(9):2134.
  4. AEMPS-ONT consensus document on the donation, collection, processing and transplantation of faecal microbiota for the treatment of Clostridioides difficile infection.