depressive disorder
Conditions
Interventions
Both interventions will be provided on top of participant*s TAU. The
intervention group will receive oral supplementation twice daily with 2 grams
of tributyrin (Taubiotic®), totalling to 4 grams of
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 up to 65 years; 2. The participant understands the study and is capable of providing written informed consent; 3. Having sufficient knowledge of the Dutch language; 4. Having a clinical diagnosis of MDD, as confirmed with The Structured Clinical Interview for the DSM-5 (SCID-5); 5. Having a depression severity of mild or higher, as reflected by a score >= 14 on the HDRS-17; 6. Receiving treatment with antidepressant medication, starting at least four weeks prior to study inclusion; 7. Daily access to a mobile phone with iOs or Android software; 8. Having a weight ranging from normal to overweight, measured as having a BMI between 18.5 and 27.5 kg/m2
Exclusion criteria
Exclusion criteria: 1. Antibiotics usage within three months before inclusion; 2. Current treatment with neuromodulation, such as deep brain stimulation, repetitive transcranial magnetic stimulation 3. Having a severe disease of the digestive tract, such as celiac disease, Crohn*s disease, active ulcerative colitis or short bowel syndrome; 4. Any psychotic disorder; 5. Acute, severe suicidal tendencies; 6. Allergy or intolerance to sunflower oil; 7. Allergy or intolerance to bovine gelatine, or unwillingness to consume soft gel capsules made of bovine gelatine;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes are the feasibility (i.e., recruitment rates, participant retention and completion, protocol adherence, success of blinding strategies) and acceptability (intake of study supplement, study participation satisfaction). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are changes in depressive symptomatology, using the HDRS-17 and the Quick Inventory of Depressive Symptomatology (QIDS), changes in anhedonia using the Temporal Experience of Pleasure Scale (TEPS) and changes in positive (PA) and negative affect (NA), and affective patterns (e.g., affect fluctuation, affect dynamics) using experience sampling methodology (ESM). Other outcomes include gastrointestinal symptoms, dietary intake, faecal microbiome composition, plasma and faecal metabolites (e.g., SCFAs), inflammatory markers in blood and intestinal permeability in blood and faeces, and a biological marker of stress (e.g., hair cortisol). | — |
Countries
Netherlands
Contacts
Public ContactA Lok
Amsterdam UMC
Outcome results
None listed