Irritable Bowel Syndrome
Conditions
Brief summary
This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS
Interventions
Saccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month
Sponsors
Hilton Pharma
Ziauddin University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire | One month | 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. |
Countries
Pakistan
Outcome results
None listed