Probiotics to Treat "Inflammatory Depression"

NCT03660280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-11-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotics

Specific probiotic lactobacilli (added to stabilized ongoing treatment)

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY
  • Region Skane

    lead OTHER

Principal Investigators

  • Daniel Lindqvist, PhD · Region Skane

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2023-09-18
Completion
2023-09-18

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03660280 on ClinicalTrials.gov