Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis

Condition(s) studied

Investigational drug(s) / intervention(s)

MBK-01: 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.

MBK-01: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of new episodes of acute diverticulitis during the trial — Up to 1 year after the start of the treatment
  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 to first episode of acute diverticulitis — Up to 1 year after the start of the treatment
  Time in weeks from the signing of the informed consent to the first episode of acute diverticulitis.
• Time to successive episodes of acute diverticulitis (other than the first episode) — Up to 1 year after the start of the treatment
  Time in weeks from the signing of the informed consent to successive episodes of acute diverticulitis (different from the first episode).
• Time between episodes of acute diverticulitis — Up to 1 year after the start of the treatment
  Time in weeks between episodes of acute diverticulitis during the trial.
• Number of hospitalizations due to acute diverticulitis in the trial — Up to 1 year after the start of the treatment
  Number of hospitalizations because of acute diverticulitis during the trial.
• Number courses of systemic antibiotic treatment used in the trial for the episodes of acute diverticulitis — Up to 1 year after the start of the treatment
  Number of systemic antibiotic treatment cycles used during the trial for the episodes of acute diverticulitis.
• Need for surgery for acute diverticulitis during the trial — Up to 1 year after the start of the treatment
  Number of patients that abandon the study because of the need for surgery for acute diverticulitis.
• Occurrence of Adverse Events (AES) — Up to 1 year after the start of the treatment
  Frequency of AES.
• Occurrence of Serious Adverse Events (SAES) — Up to 1 year after the start of the treatment
  Frequency of SAES.
• Occurrence of AES that result in discontinuation of study treatment — Up to 1 year after the start of the treatment
  Frequency of AES that result in discontinuation of study treatment.
• Occurrence of AES of special interest (AESI) — Up to 1 year after the start of the treatment
  Frequency of AESI.
• Occurrence of diverticulitis-related AES — Up to 1 year after the start of the treatment
  Frequency of diverticulitis-related AES.
• Changes in vital signs — Up to 1 year after the start of the treatment
  Frequency of patients with abnormal changes in vital signs (systolic blood pressure, diastolic blood pressure, body temperature and heart rate).
• Changes in laboratory values — Up to 1 year after the start of the treatment
  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)).
• Number of new episodes of acute diverticulitis in the trial between the two MBK-01 regimens — Up to 1 year after the start of the treatment
  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.
• Occurrence of treatment-related AES between the two MBK-01 regimens during the trial — Up to 1 year after the start of the treatment
  Frequency of AES related to the treatment with MBK-01.

Trial sites (1)