Diverticular DiseasesNCT06852274
Clostridium Butyricum CBM588® vs. Rifaximin for Symptomatic Uncomplicated Diverticular Disease (SUDD): A Real-World Retrospective Study
A study testing Clostridium butyricum CBM588® (Butirrisan®) and Rifaximin 400 mg Oral Tablet in people with Diverticular Diseases and Gastro-Intestinal Disorder, run by Dr. Amjad Khan at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Diseases, Gastro-Intestinal Disorder
- What is being tested?
- Clostridium butyricum CBM588® (Butirrisan®) and Rifaximin 400 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Diagnosed diverticulosis (confirmed by colonoscopy or CT scan)
- History of mild-to-moderate diverticulitis
- Symptomatic Uncomplicated Diverticular Disease (SUDD) requiring management
Who cannot join
- Prior abdominal surgery
- History of inflammatory bowel disease (IBD) or colorectal cancer
- Use of antibiotics or probiotics within 4 weeks prior to study entry
- Severe chronic comorbidities (e.g., advanced liver or kidney disease)
- Pregnancy or breastfeeding
- Patients with acute diverticulitis within the past 3 months
Trial locations and contacts
1 site in 1 country.
Italy1 site
Medicine & Technological Innovation Dept. University of Insubria
Varese
About this study
Official title: Management of Symptomatic Uncomplicated Diverticular Disease (SUDD) of the Colon With Clostridium Butyricum CBM588® Versus Rifaximin: Results From a Real-World Retrospective Italian Study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Diverticular Diseases, Gastro-Intestinal Disorder
- Being tested
- Clostridium butyricum CBM588® (Butirrisan®), Rifaximin 400 mg Oral Tablet
- Medical subject headings
- Diverticular Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium butyricum CBM588® (Butirrisan®)Dietary supplement
Also called Butirrisan®, PharmExtracta S.p.A.
Probiotic
Rifaximin 400 mg Oral TabletDrug
Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Clostridium butyricum CBM588® (Butirrisan®) |
| 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. Receives: Drug: Rifaximin 400 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Assessment of Safety and Tolerability of Clostridium butyricum CBM588®
Review of adverse events and overall tolerability of probiotic therapy as documented in clinical records.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Mar 2023
- Primary completion30 Apr 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diverticular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Amjad Khan
- Sponsor type
- University, hospital or other
- Collaborators
- San Giovanni Addolorata Hospital
- Responsible party
- Sponsor-investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852274
- Sponsor's protocol ID
- CESU/104/07.05.2024
- Status last verified
- May 2025
- First submitted
- 22 Feb 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41108431
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Symptomatic Uncomplicated Diverticular Disease (SUDD) of the Colon With Clostridium Butyricum CBM588® Versus Rifaximin: Results From a Real-World Retrospective Italian Study
- ClinicalTrials.gov ID
- NCT06852274
- Acronym / sponsor ID
- CESU/104/07.05.2024
- Conditions
- Diverticular Diseases, Gastro-Intestinal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dr. Amjad KhanUniversity, hospital or other
- Collaborators
- San Giovanni Addolorata Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic + Fiber Supplementation Group (Probiotic Group) | Other | Dietary Supplement: Clostridium butyricum CBM588® (Butirrisan®)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 | Drug: Rifaximin 400 mg Oral TabletParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Diagnosed diverticulosis (confirmed by colonoscopy or CT scan)
- History of mild-to-moderate diverticulitis
- Symptomatic Uncomplicated Diverticular Disease (SUDD) requiring management
Key exclusion criteria (6 listed)
- Prior abdominal surgery
- History of inflammatory bowel disease (IBD) or colorectal cancer
- Use of antibiotics or probiotics within 4 weeks prior to study entry
- Severe chronic comorbidities (e.g., advanced liver or kidney disease)
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clostridium butyricum CBM588® (Butirrisan®)Also: Butirrisan®, PharmExtracta S.p.A.Probiotic | Dietary supplement | Probiotic + Fiber Supplementation Group (Probiotic Group) |
| Rifaximin 400 mg Oral TabletAntibiotic | Drug | Rifaximin + Fiber Supplementation Group (Control Group) |
Primary outcome
Change in Symptoms of Diverticular Disease
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.
3 secondary outcomes
Assessment of Safety and Tolerability of Clostridium butyricum CBM588®
Time frame: 12 months
Incidence of Surgical Intervention in Patients with Diverticular Disease
Time frame: 12 months
Changes in Abdominal Pain Frequency, Duration, and Severity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 41108431Urgesi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clostridium butyricum CBM588® (Butirrisan®) and Rifaximin 400 mg Oral Tablet in people with Diverticular Diseases and Gastro-Intestinal Disorder, run by Dr. Amjad Khan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptoms of Diverticular Disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06852274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.