Depression Symptoms, Dietary Changes, Gut-brain Axis, Probiotics Supplement
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotics 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_SUPPLEMENTHealth diet
A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Healthy individuals aged 18 to 65 years. * Both sexes.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression score using arabic version of PHQ9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of the dietary | For 12 weeks after dietary supplement | 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 |
| Tolerability of the dietary intervention | For 12 weeks after dietary supplement | Tolerability of the dietary intervention was recorded. Participants were asked to report any adverse events or intolerances related to the dietary changes or probiotic |
| Tolerability of probiotics | For 12 weeks after dietary supplement | Tolerability of probiotics was recorded |
Countries
Egypt
Outcome results
None listed