A Phase 2 interventional study of MBK-01 and MBK-01 in Diverticulitis and Diverticulitis of Sigmoid, sponsored by Mikrobiomik Healthcare Company S.L.. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Mikrobiomik Healthcare Company S.L. · Phase 2, Interventional, and Prevention
Patients with diverticulitis experience a prolonged course of the disease and report a variety of physical, psychological and social symptoms, which highly impacts in their quality of life. Although antibiotic therapy has been the preferred treatment option for acute diverticulitis, it does not control the disease in 40 percent of the patients with complicated diverticulitis and 13 to 23 percent of the patients with non-complicated diverticulitis, which results in chronic and recurrent episodes of diverticulitis. As the episodes repeat, the outpatient conservative treatment has worse success rates and the incidence of complicated diverticulitis with abscess increases up to five times.
Therefore, it is of great importance to establish new treatments in order to avoid the recurrences of the disease. As of today, there is not enough evidence of the efficacy of current treatment options to prevent recurrences in patients with diverticulitis, but recent approaches suggest the modification of intestinal microbiota as a preventive strategy.
Microbial imbalance (dysbiosis) has been proposed as a mechanism involved in the transition from diverticulosis to diverticulitis, inflammation and some of the symptoms of the disease. In this way, fecal microbiota transplantation (FMT) could have an important role in the prevention of new episodes, as it can modify the composition of the intestinal microbiota in a less invasive and more physiological way. Until now the efficacy of FMT in patients with recurrent diverticulitis has not been assessed; however, its benefits and safety have been demonstrated in studies for inflammatory bowel disease (IBD), a pathology with similarities to diverticulitis in its symptoms and underlying inflammation.
The objective of the present clinical trial is to assess the efficacy of MBK-01 (heterologous lyophilized intestinal microbiota oral capsules) in reducing the frequency of episodes in recurrent diverticulitis, its safety and tolerability and to determine the optimal dosing regimen.
This is a phase IIa, randomized, controlled, open-label clinical trial with three treatment arms.
After an initial phase of screening, participants with recurrent diverticulitis will be randomly assigned (1:1:1) to one of the following arms:
Participants assigned to the experimental groups that receive MBK-01 will receive a pre-treatment with antibiotics that consists in the administration of amoxicillin 500 mg (1500 mg/day), fosfomycin 500 mg (3000 mg/day) and metronidazole 250 mg (750 mg/day) for 3 days. After those 3 days, participants will have a washout period of 2 days prior to starting the treatment with MBK-01.
Experimental group with MBK-01 and no maintenance dose will receive an initial dose of 4 oral capsules of MKB-01 in the first day, followed by a daily capsule during the next 16 days. In total, the participant will receive 20 capsules of MBK-01.
Experimental group with MBK-01 and maintenance dose will receive an initial dose of 4 oral capsules of MBK-01 in the first day, followed by a daily capsule during the next 16 days and a maintenance dose 3 months after finishing with the initial dose. The maintenance dose will be administered the same as the initial dose: 4 oral capsules in the first day, followed by a daily capsule during the next 16 days. In total, the participant will receive 40 oral capsules of MBK-01.
Control group with no intervention will not receive any medication oriented to prevent the recurrence of the episodes of diverticulitis.
Regardless of the treatment group to which they have been assigned, all participants will receive the usual rescue antibiotic treatment in the disease when a new episode occurs, and they can also receive the usual support measures they need during the episode (e.g. gastric protection diet or analgesics).
Objectives:
Follow up:
In addition to the initial screening visit, participants will attend to a total of 6 follow-up visits for 1 year. After the first follow-up visit, they will attend to the clinic after 1 week, 4 weeks, 16 weeks (3 months for group 2), 6 months and 1 year. During these visits: physical examination, anthropometric measurements, laboratory tests and stool samples will be taken; therapeutic adherence, acute diverticulitis episodes, hospitalizations due to acute diverticulitis and need of surgery due to acute diverticulitis will be evaluated; Gastrointestinal Quality of Life Index (GIQLI) and Short Form-36 (SF-36) questionnaires will be performed and adverse events will be monitored.
Rationale: fecal microbiota transplantation can treat the dysbiosis produced in diverticular disease by restoring the intestinal microbiota, regulating the immune system and improving the intestinal barrier function; the treatment of this dysbiosis could reduce the episodes in recurrent diverticulitis.
Donors: All donors are screened to ensure they meet the strict requirements necessary to maintain the safety of the MBK-01.
Justification:
Diverticulosis and acute diverticulitis are considered multifactorial origin diseases, affected by genetics, diet, microbial imbalance (dysbiosis), acute and chronical inflammation, altered colonic motility and neuromuscular alterations.
Current treatment of diverticular disease includes dietary fiber and pharmacological treatment with broad-spectrum antibiotics, anti-inflammatories and probiotics (alone or in combination). In addition, surgery is contemplated in severe cases.
Although antibiotic therapy has been the preferred treatment option for acute diverticulitis, it does not control the disease in 40 percent of the patients with complicated diverticulitis and 13-23% of the patients with non-complicated diverticulitis, which results in chronic and recurrent episodes of diverticulitis. As the episodes repeat, the outpatient conservative treatment has worse success rates and the incidence of complicated diverticulitis with abscess increases up to five times. Therefore, it is of great importance to establish new treatments in order to avoid the recurrence of the disease.
A preventive treatment regimen for recurrent episodes of diverticulitis has not been established yet. However, some strategies have been suggested, such as: lifestyle changes, high fiber diet, treatment with rifaximin, mesalazine and probiotics, and avoiding NSAIDs.
Microbial imbalance (dysbiosis) has been proposed as a mechanism involved in the transition from diverticulosis to diverticulitis, inflammation and some of the symptoms of the disease. It has been established that dysbiosis can lead to inflammation of the mucosa, neuromuscular dysfunction and a deterioration in the intestinal barrier. Changes in microbiota are associated with other digestive diseases, such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and Clostridioides difficile infections (CDI), which have a similar clinical presentation to diverticulitis.
Fecal microbiota transplantation could have an important role in the prevention of new episodes of diverticulitis, through the regulation of this dysbiosis. The efficacy of FMT for the treatment IBD and CDI has been clinically demonstrated, and there are also clinical trials with probiotics that show an improvement of the symptomatology in diverticular disease.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's planned enrollment of 81 is below the median of 120 across 63 interventional studies indexed under Diverticulitis.
Browse Diverticulitis studies →Mikrobiomik Healthcare Company S.L. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive MBK-01 capsules of intestinal microbiota coming from healthy donors. They will receive an initial dose of 4 capsules the first day, followed by a single daily capsule during 16 days.
Biological: MBK-01
Participants will receive MBK-01 capsules of intestinal microbiota coming from healthy donors. They will receive an initial dose of 4 capsules the first day, followed by a single daily capsule during 16 days. 3 months after the ending of the initial dose they will receive a maintenance dose, administered the same as the initial dose.
Biological: MBK-01
Participants will not receive any intervention.
Initial dose of 4 capsules of MBK-01 (heterologous lyophilized intestinal microbiota coming from healthy donors) orally the first day, followed by a single daily capsule during 16 days. Participants will receive a total dose of 20 capsules of MBK-01.
Also known as: Fecal Microbiota Transplantation, Intestinal Microbiota Transplantation
Initial dose of 4 capsules of MBK-01 (heterologous lyophilized intestinal microbiota coming from healthy donors) orally the first day, followed by a single daily capsule for 16 days and a maintenance dose 3 months after the ending of the initial dose. The maintenance dose is administered the same as the initial dose: 4 capsules of MBK-01 orally the first day, followed by a single daily capsule for 16 days. Participants will receive a total dose of 40 capsules of MBK-01.
Also known as: Fecal Microbiota Transplantation, Intestinal Microbiota Transplantation
Number of new episodes of acute diverticulitis during the trial
Diagnosis of the new episode by diagnostic imaging (computed tomography scan or ultrasound) and the presence of at least one of the following symptoms: abdominal pain, vomits, intestinal obstruction, body temperature over 38ºC, constipation, elevated acute-phase reactants leukocytes higher than 11,000 cells/µL and/or C-reactive protein higherthan 5mg/dl and/or procalcitonin higher than 0.2), hematochezia reported by the patient.
Time frame: Up to 1 year after the start of the treatment
Time to first episode of acute diverticulitis
Time in weeks from the signing of the informed consent to the first episode of acute diverticulitis.
Time frame: Up to 1 year after the start of the treatment
Time to successive episodes of acute diverticulitis (other than the first episode)
Time in weeks from the signing of the informed consent to successive episodes of acute diverticulitis (different from the first episode).
Time frame: Up to 1 year after the start of the treatment
Time between episodes of acute diverticulitis
Time in weeks between episodes of acute diverticulitis during the trial.
Time frame: Up to 1 year after the start of the treatment
Number of hospitalizations due to acute diverticulitis in the trial
Number of hospitalizations because of acute diverticulitis during the trial.
Time frame: Up to 1 year after the start of the treatment
Number courses of systemic antibiotic treatment used in the trial for the episodes of acute diverticulitis
Number of systemic antibiotic treatment cycles used during the trial for the episodes of acute diverticulitis.
Time frame: Up to 1 year after the start of the treatment
Need for surgery for acute diverticulitis during the trial
Number of patients that abandon the study because of the need for surgery for acute diverticulitis.
Time frame: Up to 1 year after the start of the treatment
Occurrence of Adverse Events (AES)
Frequency of AES.
Time frame: Up to 1 year after the start of the treatment
Occurrence of Serious Adverse Events (SAES)
Frequency of SAES.
Time frame: Up to 1 year after the start of the treatment
Occurrence of AES that result in discontinuation of study treatment
Frequency of AES that result in discontinuation of study treatment.
Time frame: Up to 1 year after the start of the treatment
Occurrence of AES of special interest (AESI)
Frequency of AESI.
Time frame: Up to 1 year after the start of the treatment
Occurrence of diverticulitis-related AES
Frequency of diverticulitis-related AES.
Time frame: Up to 1 year after the start of the treatment
Changes in vital signs
Frequency of patients with abnormal changes in vital signs (systolic blood pressure, diastolic blood pressure, body temperature and heart rate).
Time frame: Up to 1 year after the start of the treatment
Changes in laboratory values
Frequency of patients with abnormal changes in laboratory values (biochemical, hematological and coagulation, lipidic, thyroid, hepatitis B and C virus, human immunodeficiency virus (HIV) and diverticulitis related parameters (C-reactive protein and procalcitonin)).
Time frame: Up to 1 year after the start of the treatment
Number of new episodes of acute diverticulitis in the trial between the two MBK-01 regimens
Diagnosis of the new episode by diagnostic imaging (computed tomography scan or ultasound) and the presence of at least one of the following symptoms: abdominal pain, vomits, intestinal obstruction, body temperature over 38ºC, constipation, elevated acute-phase reactants leukocytes higher than 11,000 cells/µL and/or C-reactive protein higher than 5mg/dl and/or procalcitonin higher than 0.2), hematochezia reported by the patient.
Time frame: Up to 1 year after the start of the treatment
Occurrence of treatment-related AES between the two MBK-01 regimens during the trial
Frequency of AES related to the treatment with MBK-01.
Time frame: Up to 1 year after the start of the treatment
Effect of capsule-based fecal microbiota transplantation (FMT) patient-perceived on health outcome, measured by changes in the Gastrointestinal Quality of Life Index (GIQLI) questionnaire
Changes in the GIQLI questionnaire . It consists of 36 questions with an ordinal response scale, each one from 0 to 4 (0 being the worst and 4 the best score). The questionnaire includes 5 dimensions: symptoms, physical dysfunction, emotional dysfunction, social dysfunction and treatment effects. The score for each dimension is obtained by the sum of the responses for each item, divided by the number of questions in the item. A total score, which is from 0 to 144 points, can also be obtained.
Time frame: Day 0, 16 weeks (3 months for the MBK-01 group), 6 months and 1 year after the start of the treatment
Effect of capsule-based FMT patient-perceived on health outcome, measured by changes in the SF-36 questionnaire
Changes in the SF-36 questionnaire. It consists of 36 questions (items) divided into 8 dimensions. 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).
Time frame: Day 0, 16 weeks (3 months for the MBK-01 group), 6 months and 1 year after the start of the treatment.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
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