Probiotics to Treat "Inflammatory Depression"

R

Region Skane

Status

Completed

Conditions

Depression

Treatments

Dietary Supplement: Probiotics
Other: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03660280
2018/379

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age, 18-85
  • Depressive episode according to the DSM-V
  • MADRS-M score >18
  • All subjects will be stable on an antidepressant medication or in Cognitive Behavioural Therapy (CBT) for >4 weeks
  • Subjects will be willing not to significantly alter their diet during the period of the study
  • A hs-CRP value ≥1mg/L and BMI >25

Exclusion criteria

  • Serious or unstable medical illness that in the investigator's opinion could compromise response to treatment or interpretation of study results.
  • Known or suspected allergy to the study compounds.
  • Ongoing infection.
  • A diagnosis of psychotic disorder, bipolar disorder, personality disorder mental retardation, dementia, or individual whom, due to other causes, lack the ability to make an informed decision.
  • Ongoing ECT.
  • Patients who, in the investigator's judgment, pose a current, serious suicidal.
  • A diagnosis for any Substance Use Disorder (except nicotine or caffeine) in the 3 months prior to the screening visit.
  • Any medications (within 1 week of baseline or during the trial) that might confound the biomarker findings, including: Regular ingestion of NSAIDs or COX-2 inhibitors, or any use of oral steroids, immunosuppressants, interferon, chemotherapy (Patients will be instructed not to take an NSAID, COX-2 inhibitor or Aspirin in the 24 hours prior to a biomarker assessment visit).
  • Antibiotic treatment/consumption within four (4) weeks before baseline visit.
  • Patients who have taken foods or supplements with Probiotics later than two (2) weeks before baseline visit.
  • Active participation in other clinical studies with ongoing study visits.
  • Pregnancy.

Trial design

75 participants in 2 patient groups, including a placebo group

Probiotics
Experimental group
Treatment:
Dietary Supplement: Probiotics
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial documents
1

Trial contacts and locations

0

Loading...

Central trial contact

Gustav Söderberg, MD; Daniel Lindqvist, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems