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

NCT03300440 | Unknown

• 1 other identifier: 29-235 ex 16/17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders; Depression

Outcome Measures

Primary Outcomes (6)

• Changes in fecal butyrate levels [μmol/g]

  Stool diagnostics is performed by Biovis

  28 (+/- 2) days

• Changes in fecal zonulin levels [ng/ml]

  Stool diagnostics is performed by Biovis

  28 (+/- 2) days

• Changes in gastrointestinal quality of life [total score]

  Gastrointestinal quality of life index (Eypasch E, Wood-Dauphinée S, Williams JI, et al. The Gastrointestinal Quality of Life Index. A clinical index for measuring patient status in gastroenterologic surgery. Chirurg. 1993;64(4):264-274.)

  28 (+/- 2) days

• Changes in depressive symptoms [HAM-D - total score]

  Clinical assessment of Hamilton Rating Scale for Depression (Hamilton, M. A rating scale for depression. Journal of Neurology, Neurosurgery and Psychiatry. 1960;23: 56-62)

  28 (+/- 2) days

• Changes in depressive symptoms [BDI-II - total score]

  Self-rating of depressive symptoms by the patient with Beck Depression Inventory-II (Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. Journal of Personality Assessment. 1996;67 (3): 588-97.)

  28 (+/- 2) days

• Changes in overall psychological distress [SCL-90-R9 - GSI]

  GSI - global severity index of Symptom Checklist-90-Revised (Franke, GH. SCL-90-R. Die Symptom-Checkliste von Derogatis-Deutsche Version. Göttingen: Beltz, 1995.)

  28 (+/- 2) days

Study Arms (2)

Intervention group

EXPERIMENTAL

Probiotics and vitamin B7

Dietary Supplement: Probiotics and vitamin B7

Control group

PLACEBO COMPARATOR

Placebo and vitamin B7

Dietary Supplement: Placebo and vitamin B7

Interventions

Probiotics and vitamin B7 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

Also known as: Omnibiotics Stress Repair

Intervention group

Placebo and vitamin B7 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

Also known as: Biotin

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Mood Disorders; Depression

Interventions

Probiotics; Biotin

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Eva Reininghaus, PD, MD

  Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: June 21, 2017
• Primary Completion: August 1, 2018
• Study Completion: June 1, 2019
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

AU (1)