Probiotics to Treat "Inflammatory Depression" | NCT03660280

Studies
Probiotics to Treat "Inflammatory Depression"

NCT03660280

Sponsor

Region Skane

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Depression

Interventions

Probiotics
Placebo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2018Actual

Primary Completion Date

Sep 18, 2023Actual

Completion Date

Sep 18, 2023Actual

First Submitted Date

Sep 4, 2018

First Submission Date that Met QC Criteria

Sep 5, 2018

First Posted Date

Sep 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Name	Class
BioGaia AB	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Label	Type	Description	Intervention Names
Probiotics	Experimental		Dietary Supplement: Probiotics
Placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Dietary Supplement	Specific probiotic lactobacilli (added to stabilized ongoing treatment)	Probiotics

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Daniel Lindqvist, PhD	Region Skane	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Psychiatry Clinic, Lund, Region Skåne		Lund		22358	Sweden

Type	Date	Date Unknown
Release	Feb 26, 2025
Reset	Mar 13, 2025
Release	Nov 25, 2025
Reset	Dec 10, 2025

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Oct 13, 2023	Oct 13, 2023	SAP_000.pdf

ID	Term
D003863	Depression
D007249	Inflammation

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019936	Probiotics

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Intervention Model Description

Intervention will be add-on specific probiotic to ongoing treatment with antidepressant medication or Cognitive Behavioral Therapy (CBT). Subjects will be randomized to placebo or probiotic. To assure a balanced subject recruitment, block randomization within strata (ongoing treatment with CBT, antidepressant or both) will be performed. Blood sampling and symptom rating scales will be completed at baseline, at weeks 4 and 8 (end of study). Feces will be collected at baseline and end of study. Biomarkers (from baseline, week 4 and week 8) will be analyzed after the study. Subjects will be recruited from outpatient or inpatient settings, Psychiatry Skåne or primary care clinics in Skåne, Sweden. Subjects will be recruited via clinical referrals, but also via ads.

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 26, 2025			Mar 13, 2025
Nov 25, 2025