PROVIT The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders

NCT ID: NCT03300440

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-21
• Study Completion Date: 2019-06-30

Brief Summary

The aim of this study is to explore the effects of probiotics in individuals with a clinically relevant depression on psychiatric symptoms and cognition, inflammatory parameters, as well as gene-expression. The study is conducted as a placebo-controlled, randomized, double-blind, prospective, monocentric clinical study, with a two-arm parallel group design. Individuals in the intervention group receive the multispecies probiotics "Omnibiotics Stress Repair" in addition to vitamin B7, while individuals in the control group receive "Placebo" in addition to vitamin B7.

Detailed Description

The study takes places at the Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine. Individuals that start inpatient treatment at the ward in the first floor of the Department because of a major depressive episode are eligible. After inclusion into the study, the participants are asked to fill in different self-rating questionnaires (Becks-Depression Inventory-II BDI-II, Symptom Checklist-90-Revised SCL-90-R, Manie-Selbstbeurteilungsskala german adaptation of Self-Report manic inventory (SRMI) - MSS, food frequency questionnaire). General data are explored routinely, as well as a diagnostic interview (MINI - mini international neuropsychiatric interview, German version 5.0) is performed during the stay at the hospital. Participants are asked to provide a stool probe as soon as possible.

At the day after admission, fasting blood is taken (100ml). Routine parameters are further analyzed at the local laboratory, while the rest is stored at -80 degree for later analyzes. Afterwards a cognitive test-battery is performed to measure verbal learning and memory, information processing speed, cognitive flexibility and working memory capacity.

After one week a further stool probe is taken, to measure possible changes in dietary habits due to the stay at the hospital. Antidepressive treatment at the hospital is continued as treatment as usual.

At the end participants go through a similar cognitive test battery as at the beginning and are asked to fill in the same self-rating questionnaires. If participants are discharged before day 28 they are given their own preparation and instructed to take it at home in the exact same manner. An outpatient appointment at the end of the preparation intake is arranged to collect the fasting blood and stool sample and to perform the cognitive assessment.

Conditions

Mood Disorders; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

Probiotics and vitamin B7

Group Type: EXPERIMENTAL

Probiotics and vitamin B7

Intervention Type: DIETARY_SUPPLEMENT

Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form (7,5 x 109 CFU) Bacteria strains: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactobacillus acidophilus W22 Lactobacillus casei W56 Lactobacillus paracasei W20 Lactobacillus plantarum W62 Lactobacillus salivarius W24 Lactococcus lactis W19 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes

Control group

Placebo and vitamin B7

Group Type: PLACEBO_COMPARATOR

Placebo and vitamin B7

Intervention Type: DIETARY_SUPPLEMENT

Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes

Interventions

Probiotics and vitamin B7

Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form (7,5 x 109 CFU) Bacteria strains: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactobacillus acidophilus W22 Lactobacillus casei W56 Lactobacillus paracasei W20 Lactobacillus plantarum W62 Lactobacillus salivarius W24 Lactococcus lactis W19 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes

Intervention Type: DIETARY_SUPPLEMENT

Placebo and vitamin B7

Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Omnibiotics Stress Repair; Biotin

Eligibility Criteria

Inclusion Criteria

• diagnosis of mood (affective) disorders (ICD 10 F3xx)
• or neurotic, stress-related and somatoform disorders (ICD 10 F4xx),
• inpatient treatment at the ward in the first floor of the Department of Psychiatry and Psychotherapeutic Medicine in Graz
• written informed consent

Exclusion Criteria

• acute suicidality and potential dangers for themselves or other persons
• intake of antibiotics during the last month
• intake of food supplement with probiotic cultures or butyrate during the last year
• persons who are incapable of giving consent
• dementia (Mini Mental Status Examination ≤ 20)
• mental retardation
• misuse of laxatives and diuretics
• acute or chronical gastrointestinal infection or diseases
• pregnancy or breastfeeding period
• acute tumor or autoimmune diseases
• organic brain/mental disorders
• active drug or alcohol abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Reininghaus, PD, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine

Locations

Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine

Graz, Styria, Austria

Countries

Austria

Other Identifiers

29-235 ex 16/17

Identifier Type: -

Identifier Source: org_study_id