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

NCT06639646 | Completed

• 1 other identifier: MD-257-2023
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.

Conditions

Gut-brain Axis; Dietary Changes; Probiotics Supplement; Depression Symptoms

Outcome Measures

Primary Outcomes (1)

• Depression score using arabic version of PHQ9

  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.

  For 12 weeks after dietary supplement

Secondary Outcomes (3)

• 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 Arms (2)

Dietary group

EXPERIMENTAL

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: Probiotics supplements

Control group

ACTIVE COMPARATOR

A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated.

Dietary Supplement: Health diet

Interventions

Probiotics supplements DIETARY_SUPPLEMENT

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 group

Health diet DIETARY_SUPPLEMENT

A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals aged 18 to 65 years.
• Both sexes.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator in Family Medicine Department- Faculty of Medicine- Cairo University

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data was available upon a reasonable request from the corresponding author.

Locations

EG (1)