Diarrhea Dominant Irritable Bowel SyndromePhase 3SB-IBSNCT00589771
Saccharomyces Boulardii in Irritable Bowel Syndrome
A Phase 3 study testing Saccharomyces boulardii in people with Diarrhea Dominant Irritable Bowel Syndrome, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diarrhea Dominant Irritable Bowel Syndrome
- What is being tested?
- Saccharomyces boulardii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2010to Dec 2011
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diarrhea-predominant IBS satisfying ROME III criteria.
- Adults aged 18-70
Who cannot join
- Pregnant and lactating females
- Inflammatory bowel disease and other systemic disease
- Patients on anti-diarrheal and antibiotics drugs
- Patients with any ongoing infection
- Not willing to participate
- Allergy to any of Saccharomyces boulardii components
- Central venous catheter carriers
- Other probiotics e.g., Lactobacillus and Bifidobacterium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome
Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It ameliorates intestinal injury and inflammation caused by a wide variety of enteric pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant IBS and its effect on quality of life. We also plan to assess the changes in the relative production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8 and TNFα).
- Being tested
- Saccharomyces boulardii, Placebo
- Keywords
- IBS, Saccharomyces boulardii, probiotics, cytokine, histology, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces boulardiiDrug
Also called Enflor
- Saccharomyces boulardii one capsule 250mg TDS for 6 weeks
- Ispaghula husk 1 Tsf daily after dinner for six weeks
PlaceboDrug
- Cap Placebo TDS for six weeks
- Ispaghula husk 1 Tsf daily after dinner for six weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks.
2. Ispahgula husk 1 Tsf daily after dinner for six weeks. Receives: Drug: Saccharomyces boulardii |
| B | Placebo comparator | 1. Capsule Placebo TDS for six weeks.
2. Ispaghula husk 1 Tsf daily after dinner for six weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features
Measured: 6 weeks
Secondary outcomes (1)
Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea Dominant 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Biocodex
- Responsible party
- Principal investigator, Zaigham Abbas, Aga Khan University
- Investigators
- Zaigham Abbas, FACG, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589771
- Sponsor's protocol ID
- 674- MED
- Other IDs
- 2007-674MED-ERC, SB-IBS-674, SB-IBS-cytokines-674
- Acronym
- SB-IBS
- Status last verified
- Oct 2012
- First submitted
- 26 Dec 2007
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00589771
- Acronym / sponsor ID
- SB-IBS / 674- MED
- Keywords
- IBS, Saccharomyces boulardii, probiotics, cytokine, histology, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Biocodex
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jan 2008 (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.
Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It ameliorates intestinal injury and inflammation caused by a wide variety of enteric pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant IBS and its effect on quality of life. We also plan to assess the changes in the relative production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8 and TNFα).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Saccharomyces boulardii1. Capsule Saccharomyces boulardii 250 mg TDS for six weeks. 2. Ispahgula husk 1 Tsf daily after dinner for six weeks. |
| B | Placebo comparator | Drug: Placebo1. Capsule Placebo TDS for six weeks. 2. Ispaghula husk 1 Tsf daily after dinner for six weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diarrhea-predominant IBS satisfying ROME III criteria.
- Adults aged 18-70
Key exclusion criteria (8 listed)
- Pregnant and lactating females
- Inflammatory bowel disease and other systemic disease
- Patients on anti-diarrheal and antibiotics drugs
- Patients with any ongoing infection
- 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 boulardiiAlso: Enflor1. Saccharomyces boulardii one capsule 250mg TDS for 6 weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks | Drug | A |
| Placebo1. Cap Placebo TDS for six weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks | Drug | B |
Primary outcome
Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features
Time frame: 6 weeks
1 secondary outcome
Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug
Time frame: 6 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 16 Oct 2012.
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.
Zaigham Abbas, FACG 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 3 study testing Saccharomyces boulardii in people with Diarrhea Dominant 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 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 16 Oct 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features (time frame: 6 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 16 Oct 2012.