Anthropometry, Bowel Disease, Constipation, Stress
Conditions
Keywords
Probiotics, Saudi Arabia, Stress, Gut-brain axis, Gastrointestinal tract
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).
Interventions
DIETARY_SUPPLEMENTProbiotics (Lactobacillus rhamnosus GG (ATCC 53103)
Already mentioned in arm/group descriptions
Sponsors
Umm Al-Qura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Saudi Arabia
Outcome results
None listed