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Completed

NCT Number: NCT06639646

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

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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

  1. The safety of the dietary

    Time frame: 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

  2. Tolerability of the dietary intervention

    Time frame: 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

  3. Tolerability of probiotics

    Time frame: For 12 weeks after dietary supplement

    Tolerability of probiotics was recorded

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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