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

Umm Al-Qura University

Status: Completed

Conditions: Bowel Disease; Anthropometry; Constipation; Stress

Treatments: Dietary Supplement: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)

Study type: Interventional

Funder types: Other

Identifiers

NCT06464484

HAPO-02-K-012-2023-01-1414

Details and patient eligibility

About

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.

Full 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).

Enrollment: 85 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Experimental: cases

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)

Controls

No Intervention group

Description:

Had high stress levels but did not consume probiotics