Stress Clinical Trial
Official title:
The Effects Of Probiotics On Stress And Bowel Habits Among Healthy Adults From Umm Al-Qura University at Makkah: A Randomized Interventional Study
Verified date | June 2024 |
Source | Umm Al-Qura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to study the effects of probiotic supplementation on stress levels and bowel habits in healthy Saudi adults for both males and females. The main questions it aims to answer are: Does probiotic supplementation decrease stress levels? Does probiotic supplementation improve bowel habits? Researchers compared between the intervention group receiving probiotic supplements with high stress levels with a control group not receiving probiotics with high stress levels to see if probiotics decreases stress levels.
Status | Completed |
Enrollment | 85 |
Est. completion date | April 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Students at Umm Al-Qura University - Age = 18 years - Healthy individuals - Both genders - Saudi nationality Exclusion Criteria: - Diagnosed with chronic illness or/and psychiatric condition - Consumption of medications or supplements in the previous 3 months - Pregnant and breastfeeding - Smoker |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Umm Al-Qura University | Mecca |
Lead Sponsor | Collaborator |
---|---|
Umm Al-Qura University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stress | Perceived stress scale (PSS) was used in both English and Arabic versionsndividual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. |
Post intervention at 30 days | |
Primary | Bowel function | The questionnaire was developed to collect, comorbid illnesses, a prescription list, and specific questions related to bowel habits including fluid intake, usual diet, fecal matter consistency, frequency of defecation, and straining. The questionnaire also contained questions about laxative usage, previous surgeries, and lifestyle. The questionnaire was translated by an authorised translator and was based on a previous study. | Post intervention at 30 days |
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