Psychiatry Clinic, Lund, Region Skåne
Lund, 22358, Sweden
NCT Number: NCT03660280
The main aims of this project are to test if: i) Specific probiotic lactobacilli (added to stabilized ongoing treatment) are efficacious in treating depressive symptoms in individuals with low-grade inflammation, defined using high sensitivity C-reactive protein (hs-CRP) and BMI. ii) This effect is mediated through decrease of inflammation, estimated by treatment-associated changes in blood and faeces biomarkers. Secondary aims are to investigate the relationship between specific depressive symptoms and inflammation and if there is a correlation between certain pro-inflammatory or metabolic markers and depression.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Lund, 22358, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific probiotic lactobacilli (added to stabilized ongoing treatment)
Placebo
Time frame: 8 weeks
Decrease in depressive symtoms indicated by lower total score on mentioned scale, with 10 items, ranging from 0-60, a higher score indicating increased severity
Time frame: 8 weeks
Total composite score of the following items from the Patient Health Questionnaire (PHQ-9): item 3 (sleep problems), item 4 (lack of energy), and item 5 (appetite disturbance)
Time frame: 8 weeks
Total Composite score indicate severity of gastrointestinal symtoms, ranging from 0-78
Time frame: 8 weeks
Total Composite score of 17 items, measuring different hedonic domains.
Time frame: 8 weeks
Total Composite score of 36 items, measuring Health and disability within 6 different domains, ranging from 0-144.
Time frame: 8 weeks
Total Composite score of 7 items, measuring anxiety symtoms, ranging from 0-21.
Time frame: 8 weeks
Total Composite score of 7 items, ranging from 0-28
Time frame: 8 weeks
Total Composite score of 9 items, measuring severity of fatigue, ranging from 1-63
Time frame: 8 weeks
Two Composite scores of two tests measuring cognitive functioning. Symbol search, ranging from 0-60 and Digit symbol coding test ranging from 0-135.
Region Skane
Other
Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial
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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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