The Effects Of Probiotics On Stress Among Healthy Adults From Umm Al-Qura University At Makkah

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06464484
• Other study ID #: HAPO-02-K-012-2023-01-1414
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anthropometry
• Bowel Disease
• Constipation
• Stress

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