Irritable Bowel SyndromePhase 1/2IBSNCT05149599
Saccharomyces Cerevisiae for Irritable Bowel Syndrome
A Phase 1/2 study testing Saccharomyces cerevisiae in people with Irritable Bowel Syndrome, run by Ziauddin University at 1 site in Pakistan.
Trial summary
This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Saccharomyces cerevisiae
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 31 Oct 2021
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 75 years of age,
- Patients having confirmed IBS according to Rome IV criteria (newly and previously non-responder to treatment),
- Pain/ discomfort score strictly above 1 and strictly below 6 as determined on a pain/ discomfort scale using arbitrary grading from 0 to 7 in 7 days preceding the inclusion visit,
- Not hypersensitive to any of the ingredients of the drug.
Who cannot join
- Patients with an organic intestinal disease (Crohn's disease, ulcerative colitis, etc.),
- Pregnant females
- Treatments likely to influence IBS (anti-depressants, opioids, and narcotic analgesics)
- Patients with chronic alcoholism, vegetarian or vegan regimens
- Eating disorders such as anorexia or bulimia
- Documented food allergies.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr. Ziauddin University Hospital Clifton
Karachi, Sindh, 75600
About this study
Official title: Efficacy and Safety of Saccharomyces Cerevisiae for Abdominal Pain and Discomfort in Irritable Bowel Syndrome (IBS) Patients
This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Saccharomyces cerevisiae
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces cerevisiaeDrug
Saccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Treated patients | Experimental | Not described Receives: Drug: Saccharomyces cerevisiae |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score
Responders were defined as the patients who had an improvement of 50% of the weekly average intestinal pain/discomfort score compared with the baseline average score for at least 2 out of the 4 weeks of study duration
Measured: One month
Secondary outcomes (1)
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire
The IBS-QOL was evaluated using a validated 34-item IBS-QOL questionnaire, with each item scored on a 5-point Likert response scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = quite a bit, and 5 = 'extremely' or 'a great deal'). The individual responses to the 34 items of the IBS-QOL questionnaire were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation, with higher scores indicating better IBS specific quality of life.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Mar 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Collaborators
- Hilton Pharma
- Responsible party
- Principal investigator, DR MEHREEN SIYAL, Ziauddin University
- Investigators
- Mehreen Siyal, MBBS, FCPS-1, Principal investigator, DR ZIAUDDIN HOSPITAL, CLIFTON CAMPUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149599
- Sponsor's protocol ID
- 2731020MSGE
- Acronym
- IBS
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Saccharomyces Cerevisiae for Abdominal Pain and Discomfort in Irritable Bowel Syndrome (IBS) Patients
- ClinicalTrials.gov ID
- NCT05149599
- Acronym / sponsor ID
- IBS / 2731020MSGE
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Collaborators
- Hilton Pharma
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 8 Dec 2021 (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 study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated patients | Experimental | Drug: Saccharomyces cerevisiae |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients between 18 and 75 years of age,
- Patients having confirmed IBS according to Rome IV criteria (newly and previously non-responder to treatment),
- Pain/ discomfort score strictly above 1 and strictly below 6 as determined on a pain/ discomfort scale using arbitrary grading from 0 to 7 in 7 days preceding the inclusion visit,
- Not hypersensitive to any of the ingredients of the drug.
Key exclusion criteria (6 listed)
- Patients with an organic intestinal disease (Crohn's disease, ulcerative colitis, etc.),
- Pregnant females
- Treatments likely to influence IBS (anti-depressants, opioids, and narcotic analgesics)
- Patients with chronic alcoholism, vegetarian or vegan regimens
- Eating disorders such as anorexia or bulimia
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 cerevisiaeSaccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month | Drug | Treated patients |
Primary outcome
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score
Time frame: One month
Responders were defined as the patients who had an improvement of 50% of the weekly average intestinal pain/discomfort score compared with the baseline average score for at least 2 out of the 4 weeks of study duration
1 secondary outcome
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire
Time frame: One month
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 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Mehreen Siyal, MBBS, FCPS-1 principal investigator
DR ZIAUDDIN HOSPITAL, CLIFTON CAMPUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Saccharomyces cerevisiae in people with Irritable Bowel Syndrome, run by Ziauddin 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 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 7 Dec 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score (time frame: One month). 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 Dec 2022.