An interventional study of Clostridium butyricum CBM588® (Butirrisan®) and Rifaximin 400 mg Oral Tablet in Diverticular Diseases and Gastro-Intestinal Disorder, sponsored by Dr. Amjad Khan. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Dr. Amjad Khan · Not applicable, Interventional, and Treatment
Among 11 studies in Diverticular Diseases with a site in Italy — 2 open to participants now, 3 under way, none of them phase 3. Diverticular Diseases · Italy.
Among the 11 studies in Diverticular Diseases with a site in Italy, this one is one of 5 that started in 2023, is one of 3 with no phase, and was the 11th registered.
44 studies on the registry are indexed under Diverticular Diseases; 9 are open to participants now.
This study's enrollment of 70 is below the median of 81 across 31 interventional studies indexed under Diverticular Diseases.
Browse Diverticular Diseases studies →2 of the 11 studies in Diverticular Diseases with a site in Italy are open now, in 1 country. Each count lists the studies.
Of the 6 Diverticular Diseases studies recruiting now, 4 (67%) set no upper age limit and 1 (17%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2023.
Median enrollment 80 across the 7 interventional studies, 250 across the 4 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
1 of 11 have an industry lead sponsor. The 10 most frequent:
Dr. Amjad Khan is the lead sponsor of 3 studies on the registry; none are open to participants now.
Dr. Amjad Khan has 1 study filed under Diverticular Diseases — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Diverticular Diseases with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Dietary Supplement: Clostridium butyricum CBM588® (Butirrisan®)
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.
Drug: Rifaximin 400 mg Oral Tablet
Probiotic
Also known as: Butirrisan®, PharmExtracta S.p.A.
Antibiotic
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.
Time frame: 12 months
Assessment of Safety and Tolerability of Clostridium butyricum CBM588®
Review of adverse events and overall tolerability of probiotic therapy as documented in clinical records.
Time frame: 12 months
Incidence of Surgical Intervention in Patients with Diverticular Disease
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
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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Apr 2024, 13 months.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Dr. Amjad Khan