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Patients

Our mission is to save lives by leading the research and development of biologic medicines based on the human microbiome.

To this end, we are currently conducting four clinical trials. These trials are in different phases as you can see in our Pipeline.

If you have any doubts or questions about the clinical trials, want more information about them or want to know in detail the profile or requirements to be a patient in one of the trials, you can write to us at: pacientes@mikrobiomik.net

ICD-01

Trial

Phase III randomized, multicenter, controlled, open-label, multicenter clinical trial in patients with primary or recurrent Clostridioides difficile infection to evaluate the efficacy and safety of MBK-01 (freeze-dried fecal microbiota full spectrum capsules) vs fidaxomicin.

Sponsor: Mikrobiomik
Phase III
Protocol code: ICD-01
Code: EudraCT 2020-004591-17.  www.clinicaltrialsregister.eu
Status: Ongoing (recruitment)
Intermediate results: March 2023
Clinical trials: clinicaltrials.gov
Final recruitment July 2023

Participating hospitals: 21 centers in Spain.

  • Hospital Ramón y Cajal (Madrid)
  • HU 12 de Octubre (Madrid)
  • HU Puerta de Hierro (Madrid)
  • HU de Bellvitge (Barcelona)
  • Hospital Clínic (Barcelona)
  • HU Reina Sofía (Córdoba)
  • HU Son Espases (Mallorca)
  • HU Marqués de Valdecilla (Santander)
  • HU de Cruces (Bilbao)
  • HU de Basurto (Bilbao)
  • HU de Araba (Álava)
  • HU de Donostia (San Sebastián)
  • HU Lozano Blesa (Zaragoza)
  • Hospital San Pedro (Logroño)
  • HU y Politécnico La Fe (Valencia)
  • HU Gregorio Marañón (Madrid)
  • HU La Paz (Madrid)
  • HU de Alicante (Alicante)
  • HU de Gerona Doctor Josep Trueta (Gerona)
  • HU Quirónsalud Madrid (Madrid)
  • Hospital Quirónsalud Barcelona (Barcelona)

Clostridium difficilees una bacteria que puede causar diarrea y afecciones intestinales más serias, como la colitis. También se conoce con otros nombres, como Clostridioides difficile (un nombre nuevo) o C. difficile. Causa cerca de medio millón de casos en los Estados Unidos cada año.

Clostridium difficile is a bacterium that can cause diarrhea and more serious intestinal conditions, such as colitis. It is also known by other names, such as Clostridioides difficile (a new name) or C. difficile. It causes about half a million cases in the United States each year.

More information:

www.medlineplus.gov

www.mayoclinic.org

KAPEDIS

Trial

Randomized, superiority, double-blind, placebo-controlled, phase II clinical trial to demonstrate the efficacy of intestinal microbiota transplantation through the investigational biologic medicine MBK-01 in the selective intestinal decolonization of patients colonized by carbapenemase-producing Enterobacteriaceae.

Sponsor: FIBICO (Foundation for Biomedical Research of Cordoba). Mikrobiomik is supplying its investigational biologic medicine MBK-01 for the trial.
Phase II
Protocol code: KAPEDIS
EudraCT Code:  2019-003808-13
Status: Authorized by the AEMPS (Spanish Agency for Medicines and Health Products). Ongoing (recruitment).
Clinical Trials: www.clinicaltrials.gov

Participating hospitals:

  • HU Reina Sofía (Córdoba)
  • HU de Jaén
  • HU Ramón y Cajal (Madrid)
  • HU Virgen de Valme (Sevilla)
  • HU Virgen del Rocío (Sevilla)
  • HU Son Espases (Palma de Mallorca)
  • HU de Jerez de la Frontera (Cádiz)
  • HU de Málaga

Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and become unresponsive to drugs. This makes it more difficult to treat infections and increases the risk of disease spread, severe forms of illness and death.

As a result of drug resistance, antibiotics and other antimicrobial drugs become ineffective, making infections increasingly difficult or impossible to treat.

More information

www.who.int

EMOTION

Trial

Randomized, double-blind, multicenter EMOTION clinical trial to evaluate the efficacy, safety and tolerability of gut microbiota transfer via the investigational biologic medicine MBK-01 in vs. placebo for the treatment of patients with non-alcoholic steatohepatitis.

Sponsor: Mikrobiomik
Phase II
Protocol code: NASH-001
EudraCT Code: 2022-50018594-00
Status: Approved by the AEMPS (Spanish Agency for Medicines and Health Products). Start of recruitment Q3/Q4 2023.

Participating hospitals:

  • HU Marqués de Valdecilla (Santander, Cantabria)
  • HU Puerta de Hierro Majadahonda (Madrid)

Clinical trials: www.clinicaltrials.gov

Nonalcoholic fatty liver disease (NAFLD) includes a group of conditions in which there is excessive fat accumulation within the liver of people who consume no or little alcohol. The most common form of this disease is a non-serious condition known as fatty liver, in which fat accumulates inside the liver cells. Although having fat in the liver is not normal, the fat itself may not harm the liver. Among people with nonalcoholic fatty liver disease, a small group may have a more serious condition called nonalcoholic steatohepatitis (NASH). In nonalcoholic steatohepatitis, fat accumulation is associated with inflammation of liver cells and varying degrees of fibrosis. It can be a serious condition, capable of leading to extensive liver fibrosis and cirrhosis.

Cirrhosis develops when the liver suffers extensive damage and fibrous tissue gradually replaces the liver cells, leading to the liver’s inability to function properly. Some patients who develop cirrhosis may end up requiring a liver transplant.

More information

www.gi.org

www.medlineplus.gov

ONKO-01

Trial

Randomized, controlled, proof-of-concept clinical trial in cancer patients with metastatic disease from colorectal, pancreatic or gastric origin, in third and/or second or successive lines, to evaluate the efficacy, such as time to disease progression and safety of the investigational drug MBK-01 (freeze-dried fecal microbiota full spectrum capsules).

Promoter: Mikrobiomik
Phase: pproof of concept
Protocol code: ONKO-01
EudraCT code: 2022-001197-67
Status: Authorization requested in August 2022, under evaluation by the AEMPS (Spanish Agency for Medicines and Health Products). Start of recruitment Q3/Q4 2023.
Participating hospitals:   HU Fundación Jiménez Díaz (Madrid)

Cancer that spreads from where it formed to a distant part of the body is called metastatic cancer. In many types of cancer, it is also called stage IV (stage 4) cancer. The process by which cancer cells spread to other parts of the body is called metastasis.

More information

www.cancer.gov