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

Not Applicable

Completed

• Conditions: Anthropometry; Bowel Disease; Constipation; Stress
• Interventions: Dietary Supplement: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)

• Registration Number: NCT06464484
• Lead Sponsor: Umm Al-Qura University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2023-01-26
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: cases	Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)	Consumed one probiotic for 30 days everyday with or without food. Dicoflor 60 probiotic supplements were provided that contained Lactobacillus rhamnosus GG (ATCC 53103) that contained 6x10\^9 colony forming units (cpu)) per capsule.

Primary Outcome Measures

Name	Time	Method
Bowel function	Post intervention at 30 days	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.
Stress	Post intervention at 30 days	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.

Trial Locations

Locations (1)

Umm Al-Qura University; 🇸🇦 Mecca, Saudi Arabia