Probiotics Therapy of Mood Disorders

NCT04753944 | Completed

• 1 other identifier: Pomeranian Medical Univeristy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.

Conditions

Depression

Keywords

probiotics; mood; depressive; therapy

Outcome Measures

Primary Outcomes (8)

• Dietary intervention

  The verification of the past nutritional pattern (will be asses by Food Freguency Questionnarie). The indicate frequency of food consumption, respondents could choose one of six categories (next converted by researcher into daily frequency): never or very rarely (0 times/day), once a month or less (0.025 times/day), several times a month (0.1 times/day), several times a week (0.571 times/day), daily (1 time/day), or a few times a day (2 times/day)

  5 weeks

• Anthropometric measurements

  The verification of body mass during the study will be asses by body mass index (BMI). In order of this, we will measure the height (outcome in cm). BMI will be calculated by dividing body weight (in kilograms) by height squared (in meters).i Finally BMI will be presented in kg/m2.

  5 weeks

• Depression intensity mesurements

  Depression intensity will be asses by the Hamilton Rating Scale for Depression (HRSD).Unit HRSD ( 0-7 not depressed, 8-13 mild depression; 14-18 moderate depression (mild); 19-22 moderate depression; \> 23 severe depression)

  5 weeks

• The biochemical changes in stool

  Observation of biochemical changes short fatty acids (SCFAs) concentration before and after the intervention (SCFA in ng/ml)

  5 weeks

• The cytometric studies

  Observation of a change in Mean Fluorescence Intensity (FSC) of lymphocytes B and regulatory T cells before and after intervention in flow cytometry. Assessments by median: midpoint of the population (middle channel)).

  5 weeks

• The stool microbiota changes

  Changes in gut microbiota composition and metabolism (16 SrRNA bacterial genomic, bacterial metabolites) at enrollment and at the end-point ( gut microbiota will be asses in Operational taxonomic units (OTUs))

  5 weeks

• Insomnia studies

  Assessments using unique measurements Athens insomnia scale ( 0 to \< 6 means no insomnia; more than 6 points indicated diagnosis of insomnia)

  3 months

• The Kynureine Pathway

  The changes in the tryptophan pathway derivatives before and after intervention will be measured. ( we assess metabolites of kynurenine pathway e.g. 5 HT, HIAA, KYN will be asses by HPLC (in ng/ml)

  3 months

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

Patients will be introduced for 5 weeks with probiotic therapy (in the study group). They will take Ecologic®Barrier (Winclove Probiotics BV, Amsterdam, The Netherlands), consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58. The probiotic dose is going to be 4 capsules daily (one capsule contains 500 million CFUs of living probiotic strains). The treatment will be administered two times a day, during breakfast and supper. The probiotic formula will be Provided by polish distributor of Winclove products, namely Sanprobi sp. z o. o. sp. k

Dietary Supplement: Active Comparator: Probiotic

Placebo group

PLACEBO COMPARATOR

Patients will be introduced for 5 weeks with placebo that consist of maize starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily (one capsule). The treatment will be administered two times a day, during breakfast and supper.

Dietary Supplement: Placebo group

Interventions

Active Comparator: Probiotic DIETARY_SUPPLEMENT

The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.

Also known as: Probiotic Ecologic®Barrier (Winclove Probiotics BV)

Probiotic group

Placebo group DIETARY_SUPPLEMENT

Patients will be introduced for 5 weeks with placebo consisting of starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily. The treatment will be administered two times a day, during breakfast and supper.

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Perimenopausal women are qualified for examinations (based on medical and hormonal examination) at the Clinic of Gynecology, Endocrinology and Gynecology PUM.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• must presence of mood disorders confirmed by Beck scale (more than 10 points)
• must be able to swallow tablets

You may not qualify if:

• individuals that had prescribed antibiotics, proton pump inhibitors, or probiotics in the 6 months preceding the study (eg. inflammatory bowel syndrome)
• circulatory disorders patients
• diagnosed coagulopathies,
• diagnosed respiratory disease
• inflammatory bowel disease patients
• addicted to alcohol
• addicted to psychoactive substances,

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-393, Poland

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jerzy Samochowiec, prof, MD

  Pomeranian Medical University in Sczecin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and investigators enrolling participants could not foresee assignment because to conceal allocation equentially numbered probiotic containers of identical appearance was used
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of Department of Human Nutrition and Metabolimics. PhD

Model Details: Intervention, randomized, double-blind, using placebo.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: February 15, 2021
• Study Start: December 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: April 3, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)