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

Kasr El Aini Hospital

Status: Completed

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

Treatments: Dietary Supplement: Health diet; Dietary Supplement: Probiotics supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT06639646

MD-257-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

76 participants in 2 patient groups

Dietary group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotics supplements

Control group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Health diet