Our mission is to save lives through the research, development and manufacturing of biological therapies based on the human microbiome.
We currently have two active clinical trials, at different stages of development: DIREBIOT and LiverGut. Available in our Pipeline.
For inquiries regarding our clinical trials, results, additional information, or eligibility criteria, please contact us at ensayosclinicos@mikrobiomik.net
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.
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
Fecal microbiome transplantation in cirrhosis. Randomised, double-blind, placebo-controlled trial in patients with decompensated cirrhosis.
Sponsor: Centre for Biomedical Research Network Consortium (CIBER).
Phase III
Protocol code: LiverGut
EUCT number: 2023-509151-13-00
Status: Patient recruitment started in June 2025
Involved Hospitals: 8
Decompensated liver cirrhosis is an advanced stage of cirrhosis in which the liver loses its ability to perform vital functions due to irreversible tissue damage. This state is characterised by severe complications such as ascites (fluid accumulation in the abdomen), hepatic encephalopathy (neurological disturbances) and oesophageal varices, which can cause dangerous bleeding. These complications significantly increase the risk of mortality and often require hospitalisation and evaluation for possible liver transplantation.
Incidence
It is estimated that approximately 30-40% of people with cirrhosis develop complications such as ascites, hepatic encephalopathy, variceal hemorrhage or hepatorenal syndrome. Decompensated cirrhosis is most prevalent in adults over the age of 50, with a significant increase in patients over the age of 60 due to factors such as chronic alcohol consumption, chronic hepatitis and metabolic comorbidities.
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: Patient recruitment started in April 2025
Participating hospitals:
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.
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: Pending start
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.
