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| Name | Class |
|---|---|
| San Giovanni Addolorata Hospital | OTHER |
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This retrospective, real-world, single-center clinical study aimed to evaluate the effectiveness of probiotic Clostridium butyricum CBM588® (Butirrisan®) versus Rifaximin in the management of Symptomatic Uncomplicated Diverticular Disease (SUDD). Patients with diverticulosis and a history of mild-to-moderate diverticulitis were included, and their clinical outcomes were assessed using existing patient records.
The study compared two treatment groups:
Experimental Group: Clostridium butyricum CBM588® (Butirrisan®) + fiber supplementation.
Control Group: Rifaximin + fiber supplementation.
The primary endpoint was the reduction in SUDD symptoms, evaluated using patient-reported outcomes. Secondary outcomes included assessment of safety, risk of surgery, and changes in abdominal pain frequency and severity.
Diverticulosis is a common condition affecting up to 60% of individuals over 60 years old, with 10-25% developing Symptomatic Uncomplicated Diverticular Disease (SUDD). This condition is characterized by chronic low-grade inflammation, altered gut microbiota, and persistent abdominal symptoms such as bloating, pain, and irregular bowel habits.
Traditional treatment often involves cyclic rifaximin therapy. However, recent studies have highlighted the potential of microbiome-modulating therapies, including probiotics such as Clostridium butyricum CBM588®, to improve gut health, reduce inflammation, and manage SUDD symptoms.
This retrospective, real-world study reviewed clinical records of 70 patients who received treatment for SUDD at a single center. The data were extracted from routine clinical practice records, without any prospective patient recruitment. Patients were categorized into two groups:
The probiotic group received Clostridium butyricum CBM588® (Butirrisan®) with fiber supplementation.
The control group received Rifaximin 400 mg twice daily for 7-10 days per month, alongside fiber supplementation.
Outcomes were measured based on symptom relief over a 12-month period, including the frequency and severity of abdominal pain, the risk of surgery, and patient-reported outcomes. The study provided real-world evidence on the potential benefits of Clostridium butyricum CBM588® in supporting a microbiome-targeted approach for managing SUDD, potentially reducing reliance on antibiotics and improving patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic + Fiber Supplementation Group (Probiotic Group) | Other | Participants in this group received Clostridium butyricum CBM588® (Butirrisan®) probiotic at a dose of 3 tablets/day for 1 month, followed by 3 tablets/day for 2 weeks per month for 12 months, in addition to fiber supplementation. These treatments were administered as part of routine clinical care, and data were collected retrospectively from patient records. |
|
| Rifaximin + Fiber Supplementation Group (Control Group) | Other | Participants in this group received Rifaximin 400 mg twice daily for 7-10 days per month along with fiber supplementation. These treatments were administered as part of routine clinical care, and data were collected retrospectively from patient records. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clostridium butyricum CBM588® (Butirrisan®) | Dietary Supplement | Probiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptoms of Diverticular Disease | Assessment Tool: Patient-reported outcome questionnaires derived from clinical records. Description: Evaluation of symptom relief, including changes in abdominal pain, bloating, and bowel habit irregularities, based on patient records. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety and Tolerability of Clostridium butyricum CBM588® | Review of adverse events and overall tolerability of probiotic therapy as documented in clinical records. | 12 months |
| Incidence of Surgical Intervention in Patients with Diverticular Disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine & Technological Innovation Dept. University of Insubria | Varese | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41108431 | Derived | Urgesi R, Pagnini C, De Angelis F, Khan A, Pallotta L, Fanello G, Antypas P, Di Paolo MC, Villotti G, Bertuccioli A, Sisti D, Di Pierro F, Zerbinati N, Graziani MG. Management of symptomatic uncomplicated diverticular disease (SUDD) of the colon with Clostridium butyricum CBM588 versus rifaximin: a retrospective cross-sectional study. Int J Colorectal Dis. 2025 Oct 18;40(1):216. doi: 10.1007/s00384-025-05005-6. |
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This retrospective, real-world clinical study reviewed patient records to evaluate the effectiveness of Clostridium butyricum CBM588® (Butirrisan®) with fiber supplementation for managing Symptomatic Uncomplicated Diverticular Disease (SUDD). Patients who received this probiotic and fiber combination in a routine clinical setting were included. The study assessed symptom reduction, prevention of surgery, and changes in patient-reported outcomes. No prospective randomization was performed, and all data were derived from existing clinical records, reflecting routine clinical practice.
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This retrospective, real-world clinical study reviewed patient records to evaluate the effectiveness of Rifaximin with fiber supplementation for managing Symptomatic Uncomplicated Diverticular Disease (SUDD). Patients who received this antibiotic and fiber combination in a routine clinical setting were included. The study assessed symptom reduction, prevention of surgery, and changes in patient-reported outcomes. No prospective randomization was performed, and all data were derived from existing clinical records, reflecting routine clinical practice.
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| Rifaximin 400 mg Oral Tablet | Drug | Antibiotic |
|
Percentage of patients requiring surgical intervention due to complications of diverticular disease, as confirmed by medical records. Measurement Tool: Review of surgical records and patient medical charts. Unit of Measure: % of patients requiring surgery. |
| 12 months |
| Changes in Abdominal Pain Frequency, Duration, and Severity | Symptom tracking via a validated pain scale extracted from patient records. Frequency Scale: 1: <1x/week, 2: 1-2x/week, 3: 3-6x/week, 4: Daily. Duration Scale: 1: <30 min, 2: 0.5-1h, 3: 1-6h, 4: >6h. Severity Scale: 0: No pain, 1: Mild, 2: Moderate, 3: Severe, 4: Very severe. | 12 months |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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