Trials / Completed
CompletedNCT06639646
The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms .
The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Kasr El Aini Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 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. |
| DIETARY_SUPPLEMENT | Health diet | A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2024-08-01
- Completion
- 2024-08-01
- First posted
- 2024-10-15
- Last updated
- 2024-10-15
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT06639646. Inclusion in this directory is not an endorsement.