The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms, as Well as the Function and Composition of Gut Microbiota, Metabolic, Inflammation, and Oxidative Stress Markers in Patients With Depression

NCT05717946 | Unknown Phase 2

• 1 other identifier: MULodzAff_1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to gather empirical evidence which will enable to evaluate the impact of probiotic supplementation on the severity of anxiety and depressive symptoms, function, and composition of gut microbiota, metabolic parameters, inflammation, and oxidative stress markers in patients with diagnosed depressive disorders. The designed study will be prospective, randomized, placebo-controlled, and double-blind. The intervention period will last 8 weeks for each patient. The study will be conducted on 100 patients in total, who will be randomly divided into two groups, consisting of 50 patients each. Patients included in Group I (PRO-D) will receive one capsule daily containing a probiotic mixture at a daily dose of 3×109 colony-forming units (CFU). The probiotic will be composed of two bacteria strains: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175, and excipients: potato starch, magnesium stearate, and the capsule shell, made of hydroxypropylmethylcellulose. Patients included in Group II (PLC-D) will receive daily the same capsule, containing only excipients: potato starch, maltodextrin, and the capsule shell. The color, smell, and taste of the placebo will not be different from those included in the probiotic capsule. Patients will be considered compliant if they consume \>= 80% of the supplements. The primary outcome measures will be the severity of depressive anxiety and stress symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) and the Depression, Anxiety, Stress Scale (DASS) with subscales scores, the quality of life level assessed with the WHOQOL-BREF instrument. The secondary outcomes measures will include: blood pressure (BP), body mass index (BMI) and waist circumference (WC) measures, fasting glucose (fGlc), HDL cholesterol (HDL-C), triglycerides (TG), white blood cells count (WBC), neutrofiles, serum levels of C-reactive protein (CRP), the level of faecal SCFAs, faecal microbiota α-diversity and the level of oxidative stress parameters (total antioxidant capacity (TAC) and malondialdehyde (MDA)) in the blood serum.

Conditions

Depression; Anxiety

Keywords

probiotics; depression; anxiety; microbiome; metabolism

Outcome Measures

Primary Outcomes (3)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disturbances. The overall score ranges from 0 to 60 (most severe depression).

  8 weeks

• Depression, Anxiety, Stress Scale (DASS21)

  21-item self-administered questionnaire, designed to measure the magnitude of three negative emotional states: depression, anxiety, and stress. These scores ranged from 0 ("did not apply to me at all") to 3 ("apply to me very much or most of the time").

  8 weeks

• The World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)

  6-item questionnaire evaluating four domains: physical health, psychological health, social relationships, and environment validated for several countries.

  8 weeks

Secondary Outcomes (13)

• Blood pressure (BP)

  8 weeks

• Body mass index (BMI)

  8 weeks

• Waist circumference (WC)

  8 weeks

• White blood cells count (WBC)

  8 weeks

• Neutrofiles count

  8 weeks

Study Arms (2)

Group I "PRO-D"

EXPERIMENTAL

50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.

Dietary Supplement: Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.

Group II "PLC-D"

PLACEBO COMPARATOR

50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo.

Other: control group

Interventions

Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell. DIETARY_SUPPLEMENT

We plan to investigate the impact of the Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell on clinical and biochemical parameters in the experimental group.

Group I "PRO-D"

control group OTHER

We plan to investigate the impact of a placebo on clinical and biochemical parameters in the control group.

Group II "PLC-D"

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Depressive disorders diagnosed according to ICD-11,
• Age between 18 - 70 years,
• MADRS score \>=13,
• Antidepressant and antianxiety medications not changed 3 weeks prior to the recruitment visit.

You may not qualify if:

• Pregnancy,
• An infection/vaccination and/or treatment with antibiotics in the previous 4 weeks,
• Supplementation with pro- or prebiotics in the previous 4 weeks,
• Having a diagnosis of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, or severe kidney failure in the previous 4 weeks,
• body mass index (BMI)\> 35,
• glomerular filtration rate (GFR)\< 30 ml/min/1,72 m2,
• unstable thyroid dysfunction (TSH \< 0,27 or \> 4,2 μIU/ml) in the previous 4 weeks,
• Psychiatric comorbidities (except specific personality disorder, additional specific anxiety disorder, and caffeine, and nicotine addiction),
• Regular treatment (more than 3 days a week) with PPIs, metformin, laxatives, systemic steroids, or NSAIDs in the previous 4 weeks,
• Significant change in dietary pattern in the previous 4 weeks,
• Significant change in daily physical activity or extreme sports activity in the previous 4 weeks,
• Significant change in dietary supplementation in the previous 4 weeks,
• Significant change in smoking pattern in the previous 4 weeks,
• High risk of suicide,
• Is participating in, or has recently participated in, another research study involving an intervention that may alter outcomes of interest to this study,

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Central Teaching Hospital, Medical University of Lodz

Lodz, 92-216, Poland

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dominik Strzelecki, MD, PhD

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Strzelecki, MD, PhD

CONTACT

+48426757371; dominik.strzelecki@umed.lodz.pl

Anna Skowrońska, MD

CONTACT

+48426757371; anna.zabka@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind trial, independent researcher is responsible for randomization and blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Prospective, randomized, placebo-controlled, and double-blind trial

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 8, 2023
• Study Start: January 4, 2021
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the publication of both, the study protocol and results.
• Access Criteria: open access

Locations

PL (1)