Medicine & Technological Innovation Dept. University of Insubria
Varese, Italy
NCT Number: NCT06852274
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Varese, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotic
Other names: Butirrisan®, PharmExtracta S.p.A.
Antibiotic
Time frame: 12 months
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.
Time frame: 12 months
Review of adverse events and overall tolerability of probiotic therapy as documented in clinical records.
Time frame: 12 months
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.
Time frame: 12 months
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.
Dr. Amjad Khan
Other
Management of Symptomatic Uncomplicated Diverticular Disease (SUDD) of the Colon With Clostridium Butyricum CBM588® Versus Rifaximin: Results From a Real-World Retrospective Italian Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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