Status:
UNKNOWN
The Effect of Probiotic Supplementation on the Mental Status, Inflammation, and Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet
Lead Sponsor:
Medical University of Lublin
Collaborating Sponsors:
Sanprobi Sp. z o.o., Sp. k., Szczecin, Poland
Conditions:
Depressive Disorder, Major
Depression
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
More and more evidence confirms the relationship between the gut-brain-microbiota axis and the symptoms of mood disorders. A potential pathway connecting the intestines and the brain in depression is ...
Eligibility Criteria
Inclusion
- Outpatients aged 18-60 years old;
- Signed written Informed Consent Form;
- Meet the DSM-5 criteria for MDD;
- Body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2;
- MADRS (Montgomery-Asberg Depression Scale) total score at screening (V0) and at baseline (V1) of 20 points or more (moderate or severe depression);
- A willingness and motivation to follow the study protocol.
Exclusion
- Diagnosis of autoimmune, neurological, immunocompromised, thyroid, inflammatory bowel diseases, diabetes, cancers, and/or IgE-dependent allergy;
- Psychiatric comorbidities (except specific personality disorder) including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine);
- High risk of suicide in the investigator's opinion;
- An infection one month before the study baseline visit (V1);
- The use of antibiotics and/or probiotics three months prior to the study;
- Glucocorticosteroids and/or metformin treatment;
- Intake of any other drugs which in the investigator' opinion may affect the results of study;
- Intake of any dietary supplementation (except for vitamin D according to the "Vitamin D supplementation guidelines, 2018") which in the investigator' opinion may affect the results of the study;
- Changes in a pharmacotherapy and/or psychotherapy of MDD 2 weeks before the trial entry;
- Electroconvulsive therapy (ECT) 12 months before the trial entry;
- No specific diet (e.g., elimination, vegan, reduction) and changes in physical activity 4 weeks before the trial entry;
- Pregnancy or lactation.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03877393
Start Date
April 1 2019
End Date
February 1 2021
Last Update
March 15 2019
Active Locations (1)
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1
1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin
Lublin, Poland, 20439