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

Not Applicable

Completed

• Conditions: Gut-brain Axis; Dietary Changes; Probiotics Supplement; Depression Symptoms

• Registration Number: NCT06639646
• Lead Sponsor: Kasr El Aini Hospital

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.

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt