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Clinical Trials/NCT06639646
NCT06639646
Completed
Not Applicable

The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms

Kasr El Aini Hospital1 site in 1 country76 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gut-brain Axis
Sponsor
Kasr El Aini Hospital
Enrollment
76
Locations
1
Primary Endpoint
Depression score using arabic version of PHQ9
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
August 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kasr El Aini Hospital
Responsible Party
Principal Investigator
Principal Investigator

Salma Hosny Abd-allah Mohamed

Demonstrator in Family Medicine Department- Faculty of Medicine- Cairo University

Kasr El Aini Hospital

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The safety of the dietary(For 12 weeks after dietary supplement)
  • Tolerability of the dietary intervention(For 12 weeks after dietary supplement)
  • Tolerability of probiotics(For 12 weeks after dietary supplement)

Study Sites (1)

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