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

Medical University of Graz

Status

Unknown

Conditions

Depression

Mood Disorders

Treatments

Dietary Supplement: Placebo and vitamin B7

Dietary Supplement: Probiotics and vitamin B7

Study type

Interventional

Funder types

Other

Identifiers

NCT03300440

29-235 ex 16/17

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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