The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms .
NCT ID: NCT06639646
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2023-09-01
2024-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Dietary group
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.
Probiotics supplements
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.
Control group
A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated.
Health diet
A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated
Interventions
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Probiotics supplements
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 diet
A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated
Eligibility Criteria
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Inclusion Criteria
* Both sexes.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Salma Hosny Abd-allah Mohamed
Demonstrator in Family Medicine Department- Faculty of Medicine- Cairo University
Locations
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Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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MD-257-2023
Identifier Type: -
Identifier Source: org_study_id
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