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

The Effects Of Probiotics On Stress And Bowel Habits Among Healthy Adults From Umm Al-Qura University at Makkah: A Randomized Interventional Study

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Stress; Bowel Disease; Anthropometry
• Intervention / Treatment: Dietary supplement: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Mecca, Saudi Arabia, 21955
    • Umm Al-Qura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: cases; 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.	Dietary supplement: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103); Already mentioned in arm/group descriptions; Other Names: Dicoflor 60
No Intervention: Controls; Had high stress levels but did not consume probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Umm Al-Qura University
• Investigators: Principal Investigator: Essra Noorwali, PhD, Umm Al-Qura University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Stress; Probiotics; Gastrointestinal tract; Saudi Arabia; Gut-brain axis
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: HAPO-02-K-012-2023-01-1414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The following may be shared:

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No