Clinical trial NCT06639646: The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms .
Official title: The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut-brain Axis
Dietary Changes
Probiotics Supplement
Depression Symptoms
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression score using arabic version of PHQ9
timeFrame: For 12 weeks after dietary supplement
Secondary outcomes:
measure: The safety of the dietary
timeFrame: For 12 weeks after dietary supplement
measure: Tolerability of the dietary intervention
timeFrame: For 12 weeks after dietary supplement
measure: Tolerability of probiotics
timeFrame: For 12 weeks after dietary supplement
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: