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Completed

NCT Number: NCT06464484

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

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.

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Key information

Conditions

Stress Anthropometry Bowel Disease Constipation Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umm Al-Qura University

Mecca, 21955, Saudi Arabia

About this study

Participants were required to

  • Attend a visit to the nutrition clinic at Umm AL-Qura University to assess for eligibility.
  • Eligible participants were asked to sign a consent form and anthropometrics, stress, bowel habits, food records and knowledge on probiotics were collected
  • Participants were randomized based on lottery based method to an interventional or control group
  • Intervention group received 30 capsules of probiotics (Lactobacillus rhamnosus GG, 6x10^9 cpu) to be taken once daily
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)

Dietary Supplement

Already mentioned in arm/group descriptions

Other names: Dicoflor 60

Primary outcomes

  1. Stress

    Time frame: 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.

  2. Bowel function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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