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

NCT06464484 | Completed

• 1 other identifier: HAPO-02-K-012-2023-01-1414
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Constipation; Anthropometry; Bowel Disease

Keywords

Probiotics; Saudi Arabia; Stress; Gut-brain axis; Gastrointestinal tract

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental: cases

EXPERIMENTAL

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)

Controls

NO INTERVENTION

Had high stress levels but did not consume probiotics

Interventions

Probiotics (Lactobacillus rhamnosus GG (ATCC 53103) DIETARY_SUPPLEMENT

Already mentioned in arm/group descriptions

Also known as: Dicoflor 60

Experimental: cases

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Students at Umm Al-Qura University
• Age ≥ 18 years
• Healthy individuals
• Both genders
• Saudi nationality

You may not qualify if:

• Diagnosed with chronic illness or/and psychiatric condition
• Consumption of medications or supplements in the previous 3 months
• Pregnant and breastfeeding
• Smoker

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Mecca, 21955, Saudi Arabia

Location

Related Publications (1)

• Noorwali EA, Aljaadi AM, Abusudah WF, Bakhdar FA, Bin-Ali DH, Alshinawi A, Bawazir A, Mutlaq RA, Maimany HA, Barnawi LA, Murshed B, Aljared B, Azzeh FS. The effect of probiotic supplementation on perceived stress and bowel function in healthy young adults: evidence from a randomized controlled trial in Makkah. Front Nutr. 2026 Jan 6;12:1717047. doi: 10.3389/fnut.2025.1717047. eCollection 2025.

  PMID: 41567324 DERIVED

MeSH Terms

Conditions

Constipation; Intestinal Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Essra Noorwali, PhD

  Umm Al-Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This intervention was a randomized, controlled trial. The participants were randomized using lottery method either to the probiotic group (PG) and the control group (CG). The probiotic group received a daily (Lactobacillus rhamnosus GG 6x10\^9 cpu) supplement for 30 days

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: January 26, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)