Irritable Bowel SyndromePhase 4SBIBSNCT00543478
Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome
A Phase 4 study testing Saccharomyces boulardii and Methyl cellulose powder (low viscosity) in people with Irritable Bowel Syndrome, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Saccharomyces boulardii and Methyl cellulose powder (low viscosity)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2007to Jul 2008
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be recruited from gastroenterology clinic at Aga Khan University hospital with diagnosis of diarrhea dominant irritable syndrome.
- Age between 18- 60 years.
- Male and female both.
- Organic gastrointestinal diseases excluded by baseline laboratory and sigmoidoscopy/colonoscopy and biopsy within last 2 years.
- All Patients need to satisfy ROME III criteria
Who cannot join
- Age < 18 and > 60 years
- Pregnant and lactating females
- Patients on laxatives or antidiarrheal drugs that could influence the motility of gut
- Patient on antibiotics or within 2 weeks of starting protocol.
- Not willing to participate
- Non-compliant in run in period.
- Patients taking Husk.
- Diabetic patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Gastroenterology outpatients clinics,Aga Khan University hospital
Karachi, 74800
Lubna Kamani, FCPS,MRCP, 9221-4864659, lubna.kamani@aku.edu
Wasim Jafri, FRCP, 9221-4864661, wasim.jafri@aku.edu
About this study
Official title: Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome
Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology.
Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and quality of life in patients with diarrhea dominant irritable bowel syndrome?
Read the detailed description
Irritable bowel syndrome (IBS) is a common functional disorder and may lead to impaired social and personal function and can diminish quality of life.While the precise pathophysiology of IBS remains to be elucidated, dysmotility and altered visceral sensory perception are currently the most popular hypothesis. There has been a suggestion that some patients with IBS may harbor bacterial overgrowth leading to low grade inflammation, immune activation, and their symptoms may be ameliorated by its eradication.Probiotics, defined as live or attenuated bacteria or micro organism that confer a significant health benefit to the host.
- I. Firstly, probiotic organism exert antibacterial and antiviral effects.
- II. Probiotics could alter the composition of the gut flora, either directly through augmentation of commensal or indirectly through a reduction in pathogen related inflammation or bacterial fermentation.
Trial protocol:
Phase 1: placebo BID (1 week),both arms Phase 2: Randomization by pharmacy, placebo vs. active drug (6 weeks) Phase 3: placebo BID (1 week), both arms
-III. Probiotics have been demonstrated to exert anti-inflammatory effects at mucosal surfaces by reducing mucosal inflammation, decreasing immune mediated activation of enteric motor and sensory neurons and modifying neural traffic between the gut and central nervous system.
Saccharomyces Boulardii is a probiotic yeast and its role for the treatment of IBS has not been extensively investigated.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Saccharomyces boulardii, Methyl cellulose powder (low viscosity)
- Keywords
- Irritable bowel syndrome, Diarrhea, Probiotics
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces boulardiiDrug
250mg, twice a day in sachets, for 8 weeks
Methyl cellulose powder (low viscosity)Drug
twice a day sachets for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks. Receives: Drug: Saccharomyces boulardii |
| 2 | Placebo comparator | Placebo will be given twice a day for 10 weeks Receives: Drug: Methyl cellulose powder (low viscosity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence
Measured: 10 weeks
Secondary outcomes (1)
Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startOct 2007
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Lubna Kamani, FCPS,MRCP, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543478
- Sponsor's protocol ID
- SB
- Other IDs
- URC 071006MED
- Acronym
- SBIBS
- Status last verified
- Oct 2007
- First submitted
- 12 Oct 2007
- Last updated
- 15 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Saccharomyces Boulardii In Diarrhea Dominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00543478
- Acronym / sponsor ID
- SBIBS / SB
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Diarrhea, Probiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Jul 2008 (estimated)
- First posted
- 15 Oct 2007 (estimated)
- 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.
Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology.
Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and quality of life in patients with diarrhea dominant irritable bowel syndrome?
Detailed description
Irritable bowel syndrome (IBS) is a common functional disorder and may lead to impaired social and personal function and can diminish quality of life.While the precise pathophysiology of IBS remains to be elucidated, dysmotility and altered visceral sensory perception are currently the most popular hypothesis. There has been a suggestion that some patients with IBS may harbor bacterial overgrowth leading to low grade inflammation, immune activation, and their symptoms may be ameliorated by its eradication.Probiotics, defined as live or attenuated bacteria or micro organism that confer a significant health benefit to the host.
- I. Firstly, probiotic organism exert antibacterial and antiviral effects.
- II. Probiotics could alter the composition of the gut flora, either directly through augmentation of commensal or indirectly through a reduction in pathogen related inflammation or bacterial fermentation.
Trial protocol:
Phase 1: placebo BID (1 week),both arms Phase 2: Randomization by pharmacy, placebo vs. active drug (6 weeks) Phase 3: placebo BID (1 week), both arms
-III. Probiotics have been demonstrated to exert anti-inflammatory effects at mucosal surfaces by reducing mucosal inflammation, decreasing immune mediated activation of enteric motor and sensory neurons and modifying neural traffic between the gut and central nervous system.
Saccharomyces Boulardii is a probiotic yeast and its role for the treatment of IBS has not been extensively investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Saccharomyces boulardiiReceive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks. |
| 2 | Placebo comparator | Drug: Methyl cellulose powder (low viscosity)Placebo will be given twice a day for 10 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients will be recruited from gastroenterology clinic at Aga Khan University hospital with diagnosis of diarrhea dominant irritable syndrome.
- Age between 18- 60 years.
- Male and female both.
- Organic gastrointestinal diseases excluded by baseline laboratory and sigmoidoscopy/colonoscopy and biopsy within last 2 years.
- All Patients need to satisfy ROME III criteria
Key exclusion criteria (8 listed)
- Age < 18 and > 60 years
- Pregnant and lactating females
- Patients on laxatives or antidiarrheal drugs that could influence the motility of gut
- Patient on antibiotics or within 2 weeks of starting protocol.
- Not willing to participate
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 |
|---|---|---|
| Saccharomyces boulardii250mg, twice a day in sachets, for 8 weeks | Drug | 1 |
| Methyl cellulose powder (low viscosity)twice a day sachets for 10 weeks | Drug | 2 |
Primary outcome
Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence
Time frame: 10 weeks
1 secondary outcome
Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire.
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2007.
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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.
Lubna Kamani, FCPS,MRCP principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saccharomyces boulardii and Methyl cellulose powder (low viscosity) in people with Irritable Bowel Syndrome, run by Aga Khan University at 1 site in Pakistan.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Oct 2007. 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 Pakistan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lubna Kamani, FCPS, MRCP (9221-4864659, lubna.kamani@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence (time frame: 10 weeks). 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 15 Oct 2007.