Probiotics to Treat "Inflammatory Depression"

Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Placebo; Dietary supplement: Probiotics

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Lindqvist, PhD; Phone Number: +4646173885; Email: daniel.lindqvist@med.lu.se
• Study Contact Backup: Name: Gustav Söderberg, MD

Study Locations

• Sweden
  • Lund, Sweden, 22358
    • Psychiatry Clinic, Lund, Region Skåne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Serious or unstable medical illness that in the investigator's opinion could compromise response to treatment or interpretation of study results.
2. Known or suspected allergy to the study compounds.
3. Ongoing infection.
4. 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.
5. Ongoing ECT.
6. Patients who, in the investigator's judgment, pose a current, serious suicidal.
7. A diagnosis for any Substance Use Disorder (except nicotine or caffeine) in the 3 months prior to the screening visit.
8. 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).
9. Antibiotic treatment/consumption within four (4) weeks before baseline visit.
10. Patients who have taken foods or supplements with Probiotics later than two (2) weeks before baseline visit.
11. Active participation in other clinical studies with ongoing study visits.
12. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: Probiotics	Dietary supplement: Probiotics; Specific probiotic lactobacilli (added to stabilized ongoing treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg Depression Rating Scale (interview version)	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	8 weeks
"Inflammatory depressive symptoms"	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)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)	Total Composite score indicate severity of gastrointestinal symtoms, ranging from 0-78	8 weeks
Dimensional Anhedonia Rating Scale (DARS)	Total Composite score of 17 items, measuring different hedonic domains.	8 weeks
WHO Disability Assessment Schedule (WHODAS)	Total Composite score of 36 items, measuring Health and disability within 6 different domains, ranging from 0-144.	8 weeks
Generalized Anxiety Disorder-7 (GAD-7)	Total Composite score of 7 items, measuring anxiety symtoms, ranging from 0-21.	8 weeks
Insomnia Severity Index (ISI)	Total Composite score of 7 items, ranging from 0-28	8 weeks
Fatigue Severity Scale (FSS)	Total Composite score of 9 items, measuring severity of fatigue, ranging from 1-63	8 weeks
Wechsler Adult Intelligence Scale (WAIS-IV)	Two Composite scores of two tests measuring cognitive functioning. Symbol search, ranging from 0-60 and Digit symbol coding test ranging from 0-135.	8 weeks

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: BioGaia AB
• Investigators: Principal Investigator: Daniel Lindqvist, PhD, Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2018/379

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No