IBS-D (Diarrhea-predominant)PROREDINCT06676514
Study to Evaluate the Treatment Benefits of Probiotic Clostridium Butyricum CBM588® for IBS-D
A study testing Probiotic Clostridium butyricum CBM588® in people with IBS-D (Diarrhea-predominant), run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
Irritable bowel syndrome (IBS) is a prevalent gastrointestinal disorder affecting 15-20% of people in industrialized countries, often presenting as abdominal discomfort, pain, and altered bowel habits, significantly impacting quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS-D (Diarrhea-predominant)
- What is being tested?
- Probiotic Clostridium butyricum CBM588®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteItaly
- Study dates
- 10 Nov 2024to 10 Mar 2025
- 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
- male and female, aged ≥18 years
- diagnosed with IBS-D according to the Rome IV criteria
Who cannot join
- the use of antibiotic therapies
- use of laxative therapies
- the presence of organic gastrointestinal diseases
- resection of the digestive system
- the state of pregnancy or breastfeeding
- history of drug use and alcohol abuse
- the presence of an ascertained food allergy
- the presence of lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Clostridium Butyricum CBM588® on Symptoms and Quality of Life in Patients With Diarrhea-dominant Irritable Bowel Syndrome (PROREDI: (PRObiotic REmedy for DIarrhea)
Irritable bowel syndrome (IBS) is a prevalent gastrointestinal disorder affecting 15-20% of people in industrialized countries, often presenting as abdominal discomfort, pain, and altered bowel habits, significantly impacting quality of life. Among IBS subtypes, IBS-D (diarrhea-predominant) is marked by frequent, loose bowel movements, identified using the Bristol Stool Form Scale (BSFS) and classified according to Rome IV criteria. Emerging research indicates that alterations in gut microbiota, particularly a decline in butyrate-producing bacteria like *Clostridium butyricum*, play a critical role in IBS-D. Butyrate is an essential short-chain fatty acid that provides energy to colonocytes and supports intestinal health, but its deficiency may contribute to intestinal inflammation, impaired sodium and water absorption, and diarrhea. *Clostridium butyricum CBM588®* is a unique butyrate-producing bacterium that withstands oxygen, making it viable for therapeutic use. Originating from Japan, CBM588® has shown promise in enhancing gut microbiota balance, improving symptoms in IBS-D, and supporting intestinal integrity. Although primarily studied in Asian populations, additional research in Caucasian patients is warranted to validate its broader applicability and potential benefits in IBS-D symptom management.
Read the detailed description
The aim of this prospective, open-label, interventional study, based on clinical data collected from real-world clinical settings, is to assess the safety and efficacy of Clostridium butyricum CBM588® in patients with IBS-D. The study consists of two cohort groups:
A cohort, where patients will receive probiotic Butirrisan® (Clostridium butyricum CBM588®) as three tablets daily, taken in the morning either before or after breakfast, for a continuous period of eight weeks.
A control cohort, consisting of IBS-D patients who received the standard of care treatment (Trimebutin maleate followed by Lactose-free, no-slag diet).
The study evaluates changes in IBS symptom severity, fecal consistency, daily frequency of evacuation and diarrhea episodes, and quality of life at the end of the treatment. The primary outcome measures include changes in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), fecal consistency assessed through the Bristol Stool Form Scale (BSFS), and the frequency of evacuation and diarrhea episodes. Additionally, safety will be evaluated by assessing the number of patients reporting adverse effects. The secondary outcome measure is an evaluation of quality of life, assessed using a qualitative questionnaire. Comparative analyses will be performed between the prospective Butirrisan®-treated group and the control group (Trimebutin maleate + Lactose-free, no-slag diet) to determine the relative effectiveness of probiotic therapy versus standard care.
- Conditions
- IBS-D (Diarrhea-predominant)
- Being tested
- Probiotic Clostridium butyricum CBM588®, Standard of care IBS-D treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Clostridium butyricum CBM588®Dietary supplement
This group received probiotic Clostridium butyricum CBM588® treatment for IBS-D as three tablets daily for 8 weeks.
Standard of care IBS-D treatmentOther
Patients in this group received standard of care IBS-D treatment of Trimebutine maleate maleate and followed a lactose-free, no-slag diet.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | This group received probiotic treatment for IBS-D as three tablets daily for 8-weeks Receives: Dietary Supplement: Probiotic Clostridium butyricum CBM588® |
| Control group | Active comparator | This group received standard of care treatment for IBS-D. Receives: Other: Standard of care IBS-D treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Irritable Bowel Syndrome Symptom Severity Scale
The scale ranges from 0 to 500, with higher scores indicating worse symptom severity. Scores are categorized as follows: 0-75 (remission), 75-174 (mild), 175-299 (moderate), and 300-500 (severe)
Measured: 8-weeks
Changes in Fecal Consistency as assessed through the Bristol Stool Form Scale
Fecal consistency will be assessed using the Bristol Stool Form Scale, which categorizes stool from Type 1 (hard lumps) to Type 7 (liquid). Changes toward Types 3-4 indicate improvement, while shifts to Types 1 or 7 suggest worsening.
Measured: 8-weeks
Changes in patients daily frequency of evacuation and diarrhea episodes
Probiotic effect on patients frequency of evacuation and diarrhea episodes
Measured: 8-weeks
Number of patients reporting side effects
Safety evaluation of probiotic
Measured: 8-weeks
Secondary outcomes (1)
Changes in Quality of Life Assessment Questionnaire Score
Quality of life will be assessed through a qualitative scale with scores range from 1 to 5, with responses as follows: 1 = Not at all, 2 = Slightly, 3 = Moderately, 4 = Quite a lot, and 5 = Absolutely yes. Higher scores indicate a significant IBS impact on quality of life.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Nov 2024
- Primary completion24 Feb 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS-D (Diarrhea-predominant)Studies 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
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676514
- Sponsor's protocol ID
- 104_7maggio2023_Clostrydium
- Acronym
- PROREDI
- Status last verified
- May 2025
- First submitted
- 2 Nov 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Clostridium Butyricum CBM588® on Symptoms and Quality of Life in Patients With Diarrhea-dominant Irritable Bowel Syndrome (PROREDI: (PRObiotic REmedy for DIarrhea)
- ClinicalTrials.gov ID
- NCT06676514
- Acronym / sponsor ID
- PROREDI / 104_7maggio2023_Clostrydium
- Conditions
- IBS-D (Diarrhea-predominant)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 6 Nov 2024 (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.
Irritable bowel syndrome (IBS) is a prevalent gastrointestinal disorder affecting 15-20% of people in industrialized countries, often presenting as abdominal discomfort, pain, and altered bowel habits, significantly impacting quality of life. Among IBS subtypes, IBS-D (diarrhea-predominant) is marked by frequent, loose bowel movements, identified using the Bristol Stool Form Scale (BSFS) and classified according to Rome IV criteria. Emerging research indicates that alterations in gut microbiota, particularly a decline in butyrate-producing bacteria like *Clostridium butyricum*, play a critical role in IBS-D. Butyrate is an essential short-chain fatty acid that provides energy to colonocytes and supports intestinal health, but its deficiency may contribute to intestinal inflammation, impaired sodium and water absorption, and diarrhea. *Clostridium butyricum CBM588®* is a unique butyrate-producing bacterium that withstands oxygen, making it viable for therapeutic use. Originating from Japan, CBM588® has shown promise in enhancing gut microbiota balance, improving symptoms in IBS-D, and supporting intestinal integrity. Although primarily studied in Asian populations, additional research in Caucasian patients is warranted to validate its broader applicability and potential benefits in IBS-D symptom management.
Detailed description
The aim of this prospective, open-label, interventional study, based on clinical data collected from real-world clinical settings, is to assess the safety and efficacy of Clostridium butyricum CBM588® in patients with IBS-D. The study consists of two cohort groups:
A cohort, where patients will receive probiotic Butirrisan® (Clostridium butyricum CBM588®) as three tablets daily, taken in the morning either before or after breakfast, for a continuous period of eight weeks.
A control cohort, consisting of IBS-D patients who received the standard of care treatment (Trimebutin maleate followed by Lactose-free, no-slag diet).
The study evaluates changes in IBS symptom severity, fecal consistency, daily frequency of evacuation and diarrhea episodes, and quality of life at the end of the treatment. The primary outcome measures include changes in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), fecal consistency assessed through the Bristol Stool Form Scale (BSFS), and the frequency of evacuation and diarrhea episodes. Additionally, safety will be evaluated by assessing the number of patients reporting adverse effects. The secondary outcome measure is an evaluation of quality of life, assessed using a qualitative questionnaire. Comparative analyses will be performed between the prospective Butirrisan®-treated group and the control group (Trimebutin maleate + Lactose-free, no-slag diet) to determine the relative effectiveness of probiotic therapy versus standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic Clostridium butyricum CBM588®This group received probiotic treatment for IBS-D as three tablets daily for 8-weeks |
| Control group | Active comparator | Other: Standard of care IBS-D treatmentThis group received standard of care treatment for IBS-D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male and female, aged ≥18 years
- diagnosed with IBS-D according to the Rome IV criteria
Key exclusion criteria (8 listed)
- the use of antibiotic therapies
- use of laxative therapies
- the presence of organic gastrointestinal diseases
- resection of the digestive system
- the state of 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 |
|---|---|---|
| Probiotic Clostridium butyricum CBM588®This group received probiotic Clostridium butyricum CBM588® treatment for IBS-D as three tablets daily for 8 weeks. | Dietary supplement | Probiotic group |
| Standard of care IBS-D treatmentPatients in this group received standard of care IBS-D treatment of Trimebutine maleate maleate and followed a lactose-free, no-slag diet. | Other | Control group |
Primary outcome
Changes in Irritable Bowel Syndrome Symptom Severity Scale
Time frame: 8-weeks
The scale ranges from 0 to 500, with higher scores indicating worse symptom severity. Scores are categorized as follows: 0-75 (remission), 75-174 (mild), 175-299 (moderate), and 300-500 (severe)
Changes in Fecal Consistency as assessed through the Bristol Stool Form Scale
Time frame: 8-weeks
Fecal consistency will be assessed using the Bristol Stool Form Scale, which categorizes stool from Type 1 (hard lumps) to Type 7 (liquid). Changes toward Types 3-4 indicate improvement, while shifts to Types 1 or 7 suggest worsening.
Changes in patients daily frequency of evacuation and diarrhea episodes
Time frame: 8-weeks
Probiotic effect on patients frequency of evacuation and diarrhea episodes
Number of patients reporting side effects
Time frame: 8-weeks
Safety evaluation of probiotic
1 secondary outcome
Changes in Quality of Life Assessment Questionnaire Score
Time frame: 8-weeks
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 7 May 2025.
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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 Probiotic Clostridium butyricum CBM588® in people with IBS-D (Diarrhea-predominant), run by Liaquat University of Medical & Health Sciences 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 2 inclusion and 8 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 7 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?
Changes in Irritable Bowel Syndrome Symptom Severity Scale (time frame: 8-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2025.