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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06464484
Other study ID # HAPO-02-K-012-2023-01-1414
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2023
Est. completion date April 30, 2024

Study information

Verified date June 2024
Source Umm Al-Qura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Participants were required to 1. Attend a visit to the nutrition clinic at Umm AL-Qura University to assess for eligibility. 2. Eligible participants were asked to sign a consent form and anthropometrics, stress, bowel habits, food records and knowledge on probiotics were collected 3. Participants were randomized based on lottery based method to an interventional or control group 4. Intervention group received 30 capsules of probiotics (Lactobacillus rhamnosus GG, 6x10^9 cpu) to be taken once daily 5. After 30 days, all participants had to attend a second visit at the nutrition clinic at Umm Al-Qura University to assess stress levels, bowel habits and receive their incentives (discount voucher of restaurants).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)
Already mentioned in arm/group descriptions

Locations

Country Name City State
Saudi Arabia Umm Al-Qura University Mecca

Sponsors (1)

Lead Sponsor Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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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