<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03300440</url>
  </required_header>
  <id_info>
    <org_study_id>29-235 ex 16/17</org_study_id>
    <nct_id>NCT03300440</nct_id>
  </id_info>
  <brief_title>PROVIT The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders</brief_title>
  <official_title>The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders - a Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to explore the effects of probiotics in individuals with a&#xD;
      clinically relevant depression on psychiatric symptoms and cognition, inflammatory&#xD;
      parameters, as well as gene-expression. The study is conducted as a placebo-controlled,&#xD;
      randomized, double-blind, prospective, monocentric clinical study, with a two-arm parallel&#xD;
      group design. Individuals in the intervention group receive the multispecies probiotics&#xD;
      &quot;Omnibiotics Stress Repair&quot; in addition to vitamin B7, while individuals in the control group&#xD;
      receive &quot;Placebo&quot; in addition to vitamin B7.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study takes places at the Medical University of Graz, Department of Psychiatry and&#xD;
      Psychotherapeutic Medicine. Individuals that start inpatient treatment at the ward in the&#xD;
      first floor of the Department because of a major depressive episode are eligible. After&#xD;
      inclusion into the study, the participants are asked to fill in different self-rating&#xD;
      questionnaires (Becks-Depression Inventory-II BDI-II, Symptom Checklist-90-Revised SCL-90-R,&#xD;
      Manie-Selbstbeurteilungsskala german adaptation of Self-Report manic inventory (SRMI) - MSS,&#xD;
      food frequency questionnaire). General data are explored routinely, as well as a diagnostic&#xD;
      interview (MINI - mini international neuropsychiatric interview, German version 5.0) is&#xD;
      performed during the stay at the hospital. Participants are asked to provide a stool probe as&#xD;
      soon as possible.&#xD;
&#xD;
      At the day after admission, fasting blood is taken (100ml). Routine parameters are further&#xD;
      analyzed at the local laboratory, while the rest is stored at -80 degree for later analyzes.&#xD;
      Afterwards a cognitive test-battery is performed to measure verbal learning and memory,&#xD;
      information processing speed, cognitive flexibility and working memory capacity.&#xD;
&#xD;
      After one week a further stool probe is taken, to measure possible changes in dietary habits&#xD;
      due to the stay at the hospital. Antidepressive treatment at the hospital is continued as&#xD;
      treatment as usual.&#xD;
&#xD;
      At the end participants go through a similar cognitive test battery as at the beginning and&#xD;
      are asked to fill in the same self-rating questionnaires. If participants are discharged&#xD;
      before day 28 they are given their own preparation and instructed to take it at home in the&#xD;
      exact same manner. An outpatient appointment at the end of the preparation intake is arranged&#xD;
      to collect the fasting blood and stool sample and to perform the cognitive assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 21, 2017</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in fecal butyrate levels [μmol/g]</measure>
    <time_frame>28 (+/- 2) days</time_frame>
    <description>Stool diagnostics is performed by Biovis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in fecal zonulin levels [ng/ml]</measure>
    <time_frame>28 (+/- 2) days</time_frame>
    <description>Stool diagnostics is performed by Biovis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in gastrointestinal quality of life [total score]</measure>
    <time_frame>28 (+/- 2) days</time_frame>
    <description>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.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in depressive symptoms [HAM-D - total score]</measure>
    <time_frame>28 (+/- 2) days</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in depressive symptoms [BDI-II - total score]</measure>
    <time_frame>28 (+/- 2) days</time_frame>
    <description>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.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in overall psychological distress [SCL-90-R9 - GSI]</measure>
    <time_frame>28 (+/- 2) days</time_frame>
    <description>GSI - global severity index of Symptom Checklist-90-Revised (Franke, GH. SCL-90-R. Die Symptom-Checkliste von Derogatis-Deutsche Version. Göttingen: Beltz, 1995.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Mood Disorders</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Probiotics and vitamin B7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo and vitamin B7</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics and vitamin B7</intervention_name>
    <description>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</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Omnibiotics Stress Repair</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo and vitamin B7</intervention_name>
    <description>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</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Biotin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of mood (affective) disorders (ICD 10 F3xx)&#xD;
&#xD;
          -  or neurotic, stress-related and somatoform disorders (ICD 10 F4xx),&#xD;
&#xD;
          -  inpatient treatment at the ward in the first floor of the Department of Psychiatry and&#xD;
             Psychotherapeutic Medicine in Graz&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute suicidality and potential dangers for themselves or other persons&#xD;
&#xD;
          -  intake of antibiotics during the last month&#xD;
&#xD;
          -  intake of food supplement with probiotic cultures or butyrate during the last year&#xD;
&#xD;
          -  persons who are incapable of giving consent&#xD;
&#xD;
          -  dementia (Mini Mental Status Examination ≤ 20)&#xD;
&#xD;
          -  mental retardation&#xD;
&#xD;
          -  misuse of laxatives and diuretics&#xD;
&#xD;
          -  acute or chronical gastrointestinal infection or diseases&#xD;
&#xD;
          -  pregnancy or breastfeeding period&#xD;
&#xD;
          -  acute tumor or autoimmune diseases&#xD;
&#xD;
          -  organic brain/mental disorders&#xD;
&#xD;
          -  active drug or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Reininghaus, PD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 17, 2018</last_update_submitted>
  <last_update_submitted_qc>September 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Biotin</mesh_term>
    <mesh_term>Vitamin B Complex</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03300440
org study id: 29-235 ex 16/17
nct id: NCT03300440
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in fecal butyrate levels [μmol/g]
time frame: 28 (+/- 2) days
description: Stool diagnostics is performed by Biovis
measure: Changes in fecal zonulin levels [ng/ml]
time frame: 28 (+/- 2) days
description: Stool diagnostics is performed by Biovis
measure: Changes in gastrointestinal quality of life [total score]
time frame: 28 (+/- 2) days
description: 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.)
measure: Changes in depressive symptoms [HAM-D - total score]
time frame: 28 (+/- 2) days
description: 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)
measure: Changes in depressive symptoms [BDI-II - total score]
time frame: 28 (+/- 2) days
description: 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.)
measure: Changes in overall psychological distress [SCL-90-R9 - GSI]
time frame: 28 (+/- 2) days
description: GSI - global severity index of Symptom Checklist-90-Revised (Franke, GH. SCL-90-R. Die Symptom-Checkliste von Derogatis-Deutsche Version. Göttingen: Beltz, 1995.)
arm group label: Intervention group
arm group type: Experimental
description: Probiotics and vitamin B7
arm group label: Control group
arm group type: Placebo Comparator
description: Placebo and vitamin B7
intervention type: Dietary Supplement
intervention name: Probiotics and vitamin B7
description: 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
arm group label: Intervention group
other name: Omnibiotics Stress Repair
intervention type: Dietary Supplement
intervention name: Placebo and vitamin B7
description: 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
arm group label: Control group
other name: Biotin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Eva Reininghaus, PD, MD
role: Principal Investigator
affiliation: Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Mood Disorders
mesh term: Mental Disorders
mesh term: Problem Behavior
mesh term: Vitamins
mesh term: Biotin
mesh term: Vitamin B Complex