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.
Patients of both sexes aged 18-70 (both included).
Three or more episodes compatible with a diagnosis of acute diverticulitis of the left or sigmoid colon in the 3 years prior to signing the informed consent. The diagnosis of each episode of diverticulitis must have been made by demonstrating inflammation in the colon compatible with diverticulitis in an imaging test (computed tomography or ultrasound) and presenting at least one of the following analytical or clinical alterations :abdominal pain, vomiting, intestinal obstruction, body temperature over 38ºC, constipation (less than one bowel movement every 3 days), elevated acute-phase reactants (leukocytes higher than 11,000 cells/µL and/or C-reactive protein (CRP) higher than 5mg/dL and/or procalcitonin higher than 0.2), rectal bleeding.
Not having had any symptomatic episode of acute diverticulitis in the 30 days prior to signing the informed consent.
In the case of women and men of reproductive age, for safety, those who agree to follow the required contraceptive measure from the signing of the informed consent until the penultimate visit of the follow-up period.
Patients for who the information on episodes of acute diverticulitis required for inclusion in the study cannot be fully verified.
Patients with acute diverticulitis in the ascending colon, transverse colon or other locations other than the descending or sigmoid colon.
Previous colonic resection of any segment of the colon.
Medical history of colorectal cancer.
Parallel
MBK-01
Biological/VaccineInitial 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
Biological/VaccineInitial 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.
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 to first episode of acute diverticulitis
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)
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
Time in weeks between episodes of acute diverticulitis during the trial.
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.
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).
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