Gut-brain AxisNCT06639646
The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms .
A study testing Probiotics supplements and Health diet in people with Gut-brain Axis and Dietary Changes, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gut-brain Axis, Dietary Changes, Probiotics Supplement
- What is being tested?
- Probiotics supplements and Health diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy individuals aged 18 to 65 years.
- Both sexes.
Who cannot join
- Pregnancy or lactation
- Recent use of antibiotics or corticosteroids (within the past 3 months)
- Chronic medical conditions that may interfere with study participation or interpretation of results (e.g., hypo or hyperthyroidism , cancer, diabetes, cardiovascular disease)
- Current or past diagnosis of major depressive disorder or anxiety disorder
- Current use of antidepressant or anxiolytic medications
- History of gastrointestinal disorders or diseases (e.g., inflammatory bowel disease, celiac disease , malabsorbtion )
- History of substance abuse or dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms
To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.
Read the detailed description
Depression is prevalent mental health disorder that significantly impacts individuals' quality of life. Despite the availability of effective treatments such as pharmacotherapy and psychotherapy, there are still significant limitations to these approaches. Medications can have unwanted side effects and may not be effective for all patients, while psychotherapy can be time-consuming and expensive. Furthermore, many individuals may not have access to these treatments due to financial, geographical, or cultural barriers.
A more recent study published in the Journal of Pediatric Gastroenterology and Nutrition in 2020 investigated the effects of a probiotic supplement on gastrointestinal symptoms and quality of life in children with functional abdominal pain. The study found that the probiotic supplement improved gastrointestinal symptoms and quality of life in the children.
Overall, while there is limited research on probiotics in Egypt, the available studies suggest that probiotics may have potential health benefits for various populations. However, further research is needed to better understand the optimal types, doses and duration of probiotic supplementation for specific health outcomes in Egyptian populations.
- Being tested
- Probiotics supplements, Health diet
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics supplementsDietary supplement
A Dietary intervention group receiving health education message about healthy diet and probiotics supplements ( spores of poly antibiotic resistant "Lactobacilli 5 billion" in form of capsules registrated by the Egyption drug auyjority "EDA" and sold in Egyption markets under brand name "Lactèol Forte ®" capsules by Rameda® company.
The probiotic supplement is recommended to be given twice daily for 12 wks duration.
Health dietDietary supplement
A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated
| Study group | Role | What they receive |
|---|---|---|
| Dietary group | Experimental | A Dietary intervention group receiving health education message about healthy diet and probiotics supplements ( spores of poly antibiotic resistant "Lactobacilli 5 billion" in form of capsules registrated by the Egyption drug auyjority "EDA" and sold in Egyption markets under brand name "Lactèol Forte ®" capsules by Rameda® company.
The probiotic supplement is recommended to be given twice daily for 12 wks duration. Receives: Dietary Supplement: Probiotics supplements |
| Control group | Active comparator | A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated. Receives: Dietary Supplement: Health diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression score using arabic version of PHQ9
Depression score using arabic version of PHQ9 was recorded .The PHQ-9 (Patient Health Questionnaire-9) is a tool used to assess the severity of depression. It consists of nine questions, each related to symptoms experienced over the past two weeks. Each question is scored from 0 to 3, with the total score ranging from 0 to 27.
Measured: For 12 weeks after dietary supplement
Secondary outcomes (3)
The safety of the dietary
The safety of the dietary intervention and probiotics was recorded. Participants were asked to report any adverse events or intolerances related to the dietary changes or probiotic
Measured: For 12 weeks after dietary supplement
Tolerability of the dietary intervention
Tolerability of the dietary intervention was recorded. Participants were asked to report any adverse events or intolerances related to the dietary changes or probiotic
Measured: For 12 weeks after dietary supplement
Tolerability of probiotics
Tolerability of probiotics was recorded
Measured: For 12 weeks after dietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut-brain AxisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Hosny Abd-allah Mohamed, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639646
- Sponsor's protocol ID
- MD-257-2023
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms
- ClinicalTrials.gov ID
- NCT06639646
- Acronym / sponsor ID
- MD-257-2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 15 Oct 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.
To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.
Detailed description
Depression is prevalent mental health disorder that significantly impacts individuals' quality of life. Despite the availability of effective treatments such as pharmacotherapy and psychotherapy, there are still significant limitations to these approaches. Medications can have unwanted side effects and may not be effective for all patients, while psychotherapy can be time-consuming and expensive. Furthermore, many individuals may not have access to these treatments due to financial, geographical, or cultural barriers.
A more recent study published in the Journal of Pediatric Gastroenterology and Nutrition in 2020 investigated the effects of a probiotic supplement on gastrointestinal symptoms and quality of life in children with functional abdominal pain. The study found that the probiotic supplement improved gastrointestinal symptoms and quality of life in the children.
Overall, while there is limited research on probiotics in Egypt, the available studies suggest that probiotics may have potential health benefits for various populations. However, further research is needed to better understand the optimal types, doses and duration of probiotic supplementation for specific health outcomes in Egyptian populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary group | Experimental | Dietary Supplement: Probiotics supplementsA Dietary intervention group receiving health education message about healthy diet and probiotics supplements ( spores of poly antibiotic resistant "Lactobacilli 5 billion" in form of capsules registrated by the Egyption drug auyjority "EDA" and sold in Egyption markets under brand name "Lactèol Forte ®" capsules by Rameda® company. The probiotic supplement is recommended to be given twice daily for 12 wks duration. |
| Control group | Active comparator | Dietary Supplement: Health dietA Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy individuals aged 18 to 65 years.
- Both sexes.
Key exclusion criteria (7 listed)
- Pregnancy or lactation
- Recent use of antibiotics or corticosteroids (within the past 3 months)
- Chronic medical conditions that may interfere with study participation or interpretation of results (e.g., hypo or hyperthyroidism , cancer, diabetes, cardiovascular disease)
- Current or past diagnosis of major depressive disorder or anxiety disorder
- Current use of antidepressant or anxiolytic medications
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 supplementsA Dietary intervention group receiving health education message about healthy diet and probiotics supplements ( spores of poly antibiotic resistant "Lactobacilli 5 billion" in form of capsules registrated by the Egyption drug auyjority "EDA" and sold in Egyption markets under brand name "Lactèol Forte ®" capsules by Rameda® company. The probiotic supplement is recommended to be given twice daily for 12 wks duration. | Dietary supplement | Dietary group |
| Health dietA Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated | Dietary supplement | Control group |
Primary outcome
Depression score using arabic version of PHQ9
Time frame: For 12 weeks after dietary supplement
Depression score using arabic version of PHQ9 was recorded .The PHQ-9 (Patient Health Questionnaire-9) is a tool used to assess the severity of depression. It consists of nine questions, each related to symptoms experienced over the past two weeks. Each question is scored from 0 to 3, with the total score ranging from 0 to 27.
3 secondary outcomes
The safety of the dietary
Time frame: For 12 weeks after dietary supplement
Tolerability of the dietary intervention
Time frame: For 12 weeks after dietary supplement
Tolerability of probiotics
Time frame: For 12 weeks after dietary supplement
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 15 Oct 2024.
- Individual participant dataSharing planned: Yes. The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Gut-brain Axis
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Alcohol Use Disorder (AUD), Alcohol Abstinence
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 supplements and Health diet in people with Gut-brain Axis and Dietary Changes, run by Kasr El Aini Hospital at 1 site in Egypt.
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 2 inclusion and 7 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 15 Oct 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 Egypt. 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?
Depression score using arabic version of PHQ9 (time frame: For 12 weeks after dietary supplement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.