Cairo University
Cairo, Egypt
NCT Number: NCT06639646
To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
A Control group receiving health education about healthy diet. At the end of the 12 wk. period, the same measurements are repeated
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.
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
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
Time frame: For 12 weeks after dietary supplement
Tolerability of probiotics was recorded
Kasr El Aini Hospital
Other
The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms
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.
Published trials that share one or more normalized conditions with this study.
NCT07457242
Adult, Behavior
View Trial DetailsNCT07679490
Asymptomatic Diseases, Asymptomatic Infections
Dublin, Dublin 04, Ireland
View Trial DetailsNCT06707636
Awareness, Behavior
Cincinnati, Ohio, United States
View Trial DetailsNCT07605975
Behavior, Behavioral Symptoms
Minneapolis, Minnesota, United States
View Trial Details