StressNCT06464484
The Effects Of Probiotics On Stress Among Healthy Adults From Umm Al-Qura University At Makkah
A study testing Probiotics (Lactobacillus rhamnosus GG (ATCC 53103) in people with Stress and Constipation, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Constipation, Anthropometry
- What is being tested?
- Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 26 Jan 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students at Umm Al-Qura University
- Age ≥ 18 years
- Healthy individuals
- Both genders
- Saudi nationality
Who cannot join
- Diagnosed with chronic illness or/and psychiatric condition
- Consumption of medications or supplements in the previous 3 months
- Pregnant and breastfeeding
- Smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects Of Probiotics On Stress And Bowel Habits Among Healthy Adults From Umm Al-Qura University at Makkah: A Randomized Interventional Study
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.
Read the detailed description
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).
- Conditions
- Stress, Constipation, Anthropometry, Bowel Disease
- Being tested
- Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)
- Keywords
- Probiotics, Saudi Arabia, Stress, Gut-brain axis, Gastrointestinal tract
- Medical subject headings
- Constipation, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)Dietary supplement
Also called Dicoflor 60
Already mentioned in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103) |
| Controls | No intervention | Had high stress levels but did not consume probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post intervention at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start26 Jan 2023
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essra Noorwali, Umm Al-Qura University
- Investigators
- Essra Noorwali, PhD, Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464484
- Sponsor's protocol ID
- HAPO-02-K-012-2023-01-1414
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The following may be shared: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Publications
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.
PubMed 41567324
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Probiotics On Stress And Bowel Habits Among Healthy Adults From Umm Al-Qura University at Makkah: A Randomized Interventional Study
- ClinicalTrials.gov ID
- NCT06464484
- Acronym / sponsor ID
- HAPO-02-K-012-2023-01-1414
- Conditions
- Stress, Constipation, Anthropometry, Bowel Disease
- Keywords
- Probiotics, Saudi Arabia, Stress, Gut-brain axis, Gastrointestinal tract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental: cases | Experimental | Dietary Supplement: Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Students at Umm Al-Qura University
- Age ≥ 18 years
- Healthy individuals
- Both genders
- Saudi nationality
Key exclusion criteria (4 listed)
- Diagnosed with chronic illness or/and psychiatric condition
- Consumption of medications or supplements in the previous 3 months
- Pregnant and breastfeeding
- Smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics (Lactobacillus rhamnosus GG (ATCC 53103)Also: Dicoflor 60Already mentioned in arm/group descriptions | Dietary supplement | Experimental: cases |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Derived from this study: PubMed 41567324Noorwali 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essra Noorwali, PhD principal investigator
Umm Al-Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (Lactobacillus rhamnosus GG (ATCC 53103) in people with Stress and Constipation, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Post intervention at 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.