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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

FINALIZED

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: Finished (November 2023)
Intermediate results: March 2023
Final results: April 2024
Clinical trials: clinicaltrials.gov
Final recruitment: November 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)

CDI arises when the colon becomes colonized by C. difficile bacteria, resulting in an imbalance of gut microorganisms. This imbalance is primarily triggered by antibiotic use. CDI leads to a range of symptoms, ranging from watery diarrhea to life-threatening colitis.
Clinical manifestation

  • Colonization of the distal segment: despite CDI can affect any part of the colon, the distal segment is the zone most commonly affected. Treatment should not be initiated solely based on a positive laboratory test for C. difficile without any accompanying symptoms.
  • Watery diarrhea: occurs in most cases during, or directly after, antimicrobial therapy, although CDI onset might be also a couple of weeks afterwards.
  • Other clinical features: abdominal pain, fever, nausea, vomiting, weakness, and loss of appetite.
  • Toxins: C. difficile produces two types of toxins, enterotoxin A and cytotoxin B. These toxins are transported to the cell cytoplasm disestablishing the cell cytoskeleton and causing inflammatory process and tissue damage.

More information:

www.medlineplus.gov

www.mayoclinic.org

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 Q2 2024.

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 2024.
Participating hospitals:   HU Fundación Jiménez Díaz (Madrid)

Colon cancer is the most frequent type of tumor or with the highest incidence in Spain if we consider the general population. This tumor affects the large intestine, which is the final part of the digestive system. Sometimes we call it colorectal cancer, because the rectum is the last area that connects with the outside through the anus. The person may present various symptoms, sometimes non-specific, but generally digestive complaints.

More information

www.contraelcancer.es

DIREBIOT

Trial

Phase IIa, randomized, controlled, open-label clinical trial to evaluate the efficacy, safety and tolerability of the biological medicine MBK-01, oral capsules FSPIM (Full Spectrum & Purified Intestinal Microbiota). As well as the determination of its optimized dose in the treatment of patients with recurrent diverticulitis.

Sponsor: Mikrobiomik
Phase IIa
Protocol code: DIREBIOT
EUCT number: 2023-506224-87-00
Status: Approve by the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios). Recruitment starts Q3/Q4 2024.

Participating hospitals:

  • Ramón y Cajal Hospital (Madrid)

The presence of diverticula in the colon is called diverticulosis and in most cases is asymptomatic. When symptomatology develops we speak of diverticular disease, and if it is severe it is known as acute diverticulitis. Acute diverticulitis in turn can be uncomplicated (DANC) or complicated (DAC).

Although there are various recommendations, there is no established treatment to prevent recurrence of diverticulitis, and the risk of recurrence after a first episode is between 7-45%. In general, patients with diverticular disease have a prolonged course of the disease and recurrent symptoms, which has an impact on their quality of life. Due to the role of the microbiota in the disease, we propose to administer freeze-dried fecal microbiota obtained from healthy donors in oral capsules, with the aim of restoring the microbiota and limiting the recurrence of the disease.