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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.
Participants were required to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Controls | No Intervention | Had high stress levels but did not consume probiotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics (Lactobacillus rhamnosus GG (ATCC 53103) | Dietary Supplement | Already mentioned in arm/group descriptions |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Essra Noorwali, PhD | Umm Al-Qura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umm Al-Qura University | Mecca | 21955 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41567324 | Derived | 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. |
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The following may be shared:
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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
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| D004066 | Digestive System Diseases |
| D019602 |
| Food and Beverages |