Mood DisordersNCT03300440
PROVIT The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders
A study testing Probiotics and vitamin B7 in people with Mood Disorders and Depression, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mood Disorders, Depression
- What is being tested?
- Probiotics and vitamin B7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 21 Jun 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine
Graz, Styria, 8036
About this study
Official title: The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders - a Clinical Study
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.
Read the 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
- Being tested
- Probiotics and vitamin B7, Placebo and vitamin B7
- Medical subject headings
- Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics and vitamin B7Dietary supplement
Also called Omnibiotics Stress Repair
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
Placebo and vitamin B7Dietary supplement
Also called Biotin
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Probiotics and vitamin B7 Receives: Dietary Supplement: Probiotics and vitamin B7 |
| Control group | Placebo comparator | Placebo and vitamin B7 Receives: Dietary Supplement: Placebo and vitamin B7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fecal butyrate levels [μmol/g]
Stool diagnostics is performed by Biovis
Measured: 28 (+/- 2) days
Changes in fecal zonulin levels [ng/ml]
Stool diagnostics is performed by Biovis
Measured: 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.)
Measured: 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)
Measured: 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.)
Measured: 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.)
Measured: 28 (+/- 2) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start21 Jun 2017
- Primary completion1 Aug 2018
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Reininghaus, PD, MD, Principal investigator, Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300440
- Sponsor's protocol ID
- 29-235 ex 16/17
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders - a Clinical Study
- ClinicalTrials.gov ID
- NCT03300440
- Acronym / sponsor ID
- 29-235 ex 16/17
- Conditions
- Mood Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- Jun 2019 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Probiotics and vitamin B7Probiotics and vitamin B7 |
| Control group | Placebo comparator | Dietary Supplement: Placebo and vitamin B7Placebo and vitamin B7 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics and vitamin B7Also: Omnibiotics Stress RepairPowder; 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 | Dietary supplement | Intervention group |
| Placebo and vitamin B7Also: BiotinPowder; 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 | Dietary supplement | Control group |
Primary outcome
Changes in fecal butyrate levels [μmol/g]
Time frame: 28 (+/- 2) days
Stool diagnostics is performed by Biovis
Changes in fecal zonulin levels [ng/ml]
Time frame: 28 (+/- 2) days
Stool diagnostics is performed by Biovis
Changes in gastrointestinal quality of life [total score]
Time frame: 28 (+/- 2) days
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.)
Changes in depressive symptoms [HAM-D - total score]
Time frame: 28 (+/- 2) days
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)
Changes in depressive symptoms [BDI-II - total score]
Time frame: 28 (+/- 2) days
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.)
Changes in overall psychological distress [SCL-90-R9 - GSI]
Time frame: 28 (+/- 2) days
GSI - global severity index of Symptom Checklist-90-Revised (Franke, GH. SCL-90-R. Die Symptom-Checkliste von Derogatis-Deutsche Version. Göttingen: Beltz, 1995.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Reininghaus, PD, MD principal investigator
Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and vitamin B7 in people with Mood Disorders and Depression, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fecal butyrate levels [μmol/g] (time frame: 28 (+/- 2) days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.