<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/NCT04484467</url>
  </required_header>
  <id_info>
    <org_study_id>No. 418 dated 01/31/2018</org_study_id>
    <nct_id>NCT04484467</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome</brief_title>
  <official_title>Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal Stare Budgetary Scientific Institution, Mental Health Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RML INVEST, Torkhovsky passage 10, Tula, Russian Federation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal Stare Budgetary Scientific Institution, Mental Health Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of a food supplement with&#xD;
      standardized menthol, limonene, and gingerol content in patients with irritable bowel&#xD;
      syndrome (IBS) or IBS/functional dyspepsia (FD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using a random number generator, 56 patients meeting inclusion criteria with IBS or IBS/FD&#xD;
      were randomly assigned to either the intervention group (28 individuals) or the control group&#xD;
      (28 individuals) (Table 2). Non-functional causes for the symptoms were excluded by a&#xD;
      detailed evaluation of the medical history, physical examination, extensive panel of blood&#xD;
      tests, stool analysis, and colonoscopy with biopsies.&#xD;
&#xD;
      Diarrhoea-predominant IBS patients (IBS-D) and mixed bowel habits IBS patients (IBS-M) were&#xD;
      treated with smooth muscle antispasmodics. The constipation-predominant IBS patients (IBS-C)&#xD;
      were treated with smooth muscle antispasmodics and laxatives. IBS/FD patients were treated&#xD;
      with smooth muscle antispasmodics and proton pump inhibitors.&#xD;
&#xD;
      At Visit 1, all patients were randomly assigned into two groups. In the intervention group&#xD;
      (Group 1), the supplement &quot;Standart Zdorovya GASTRO&quot; (1 capsule, 730 mg, once a day) was&#xD;
      added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo&#xD;
      (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days&#xD;
      (Table 1). Researchers and patients were not informed who received a supplement or placebo.&#xD;
      During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1,&#xD;
      Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).&#xD;
&#xD;
      Symptom severity was assessed on each visit using &quot;7x7&quot; questionnaire [Ivashkin, V.,&#xD;
      Sheptulin, A., Shifrin, O., Poluektova, E., Pavlov, C., Ivashkin, K., Drozdova, A.,&#xD;
      Lyashenko, O., Korolev, A., 2019. Clinical validation of the &quot;7 × 7&quot; questionnaire for&#xD;
      patients with functional gastrointestinal disorders. J. Gastroenterol. Hepatol. 34,&#xD;
      1042-1048. https://doi.org/10.1111/jgh.14546], on 1 and 3 visits stool samples were collected&#xD;
      for the qualitative and quantitative composition of the intestinal microbiota based on 16S&#xD;
      rRNA gene sequencing.&#xD;
&#xD;
      The study protocol was approved by the Ethics Committee of the Mental Health Research Center,&#xD;
      Moscow, Russian Federation (No. 418 dated 01/31/2018) and written informed consent was&#xD;
      obtained from all participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2018</start_date>
  <completion_date type="Actual">December 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 28, 2019</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>
    <intervention_model_description>At Visit 1, all patients were randomly assigned into two groups. In the intervention group (Group 1), the supplement &quot;Standart Zdorovya GASTRO&quot; (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (Table 1). During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1, Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Using a random number generator, 56 patients with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or control group (28 individuals).&#xD;
Researchers and patients were not informed who received a supplement or placebo.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the severity of symptoms of irritable bowel syndrome (IBS) and functional dyspepsia (FD) (constipation-predominant, diarrhea-predominant, mixed-type IBS and IBS/FD)</measure>
    <time_frame>Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days</time_frame>
    <description>Symptom severity was tested with a &quot;7x7&quot; questionnaire at each visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the number of SCFA producing bacteria</measure>
    <time_frame>Visit 1 - Day 1, Visit 3 - Day 30 + 2 days</time_frame>
    <description>The qualitative and quantitative composition of the intestinal microbiota was assessed at Visits 1 and 3 based on 16S rRNA gene sequencing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Irritable Bowel Syndrome With Diarrhea</condition>
  <condition>Irritable Bowel Syndrome With Constipation</condition>
  <condition>Irritable Bowel Syndrome Mixed</condition>
  <arm_group>
    <arm_group_label>Food supplement Standart Zdorovya GASTRO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention group (Group 1), the supplement &quot;Standart Zdorovya GASTRO&quot; (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Food Supplement With Standardized Menthol, Limonene, and Ginger</intervention_name>
    <description>Components of Standart Zdorovya GASTRO: Peppermint oil (40% menthol, 1.5% limonene) - 240 mg, Ginger oil (14% gingerol) - 50 mg, olive oil - 440 mg, 1 capsule, 730 mg, once a day for 30 days</description>
    <arm_group_label>Food supplement Standart Zdorovya GASTRO</arm_group_label>
    <other_name>Standart Zdorovya GASTRO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  irritable bowel syndrome (IBS)&#xD;
&#xD;
          -  diarrhea-predominant IBS&#xD;
&#xD;
          -  constipation-predominant IBS&#xD;
&#xD;
          -  mixed-type IBS&#xD;
&#xD;
          -  IBS/functional dyspepsia symptoms&#xD;
&#xD;
          -  Must be able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  organic bowel disease&#xD;
&#xD;
          -  renal disease&#xD;
&#xD;
          -  hepatic insufficiency,&#xD;
&#xD;
          -  schizophrenia&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mental Health Research Center</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal Stare Budgetary Scientific Institution, Mental Health Research Center</investigator_affiliation>
    <investigator_full_name>Allan G. Beniashvilia</investigator_full_name>
    <investigator_title>Senior research fellow, PHD</investigator_title>
  </responsible_party>
  <keyword>Functional dyspepsia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Constipation</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menthol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04484467
org study id: No. 418 dated 01/31/2018
nct id: NCT04484467
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the efficacy and safety of a food supplement with
      standardized menthol, limonene, and gingerol content in patients with irritable bowel
      syndrome (IBS) or IBS/functional dyspepsia (FD).
Using a random number generator, 56 patients meeting inclusion criteria with IBS or IBS/FD
      were randomly assigned to either the intervention group (28 individuals) or the control group
      (28 individuals) (Table 2). Non-functional causes for the symptoms were excluded by a
      detailed evaluation of the medical history, physical examination, extensive panel of blood
      tests, stool analysis, and colonoscopy with biopsies.

      Diarrhoea-predominant IBS patients (IBS-D) and mixed bowel habits IBS patients (IBS-M) were
      treated with smooth muscle antispasmodics. The constipation-predominant IBS patients (IBS-C)
      were treated with smooth muscle antispasmodics and laxatives. IBS/FD patients were treated
      with smooth muscle antispasmodics and proton pump inhibitors.

      At Visit 1, all patients were randomly assigned into two groups. In the intervention group
      (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was
      added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo
      (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days
      (Table 1). Researchers and patients were not informed who received a supplement or placebo.
      During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1,
      Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).

      Symptom severity was assessed on each visit using "7x7" questionnaire [Ivashkin, V.,
      Sheptulin, A., Shifrin, O., Poluektova, E., Pavlov, C., Ivashkin, K., Drozdova, A.,
      Lyashenko, O., Korolev, A., 2019. Clinical validation of the "7 × 7" questionnaire for
      patients with functional gastrointestinal disorders. J. Gastroenterol. Hepatol. 34,
      1042-1048. https://doi.org/10.1111/jgh.14546], on 1 and 3 visits stool samples were collected
      for the qualitative and quantitative composition of the intestinal microbiota based on 16S
      rRNA gene sequencing.

      The study protocol was approved by the Ethics Committee of the Mental Health Research Center,
      Moscow, Russian Federation (No. 418 dated 01/31/2018) and written informed consent was
      obtained from all participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: At Visit 1, all patients were randomly assigned into two groups. In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (Table 1). During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1, Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Using a random number generator, 56 patients with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or control group (28 individuals).
Researchers and patients were not informed who received a supplement or placebo.
measure: Change in the severity of symptoms of irritable bowel syndrome (IBS) and functional dyspepsia (FD) (constipation-predominant, diarrhea-predominant, mixed-type IBS and IBS/FD)
time frame: Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days
description: Symptom severity was tested with a "7x7" questionnaire at each visit.
measure: Change in the number of SCFA producing bacteria
time frame: Visit 1 - Day 1, Visit 3 - Day 30 + 2 days
description: The qualitative and quantitative composition of the intestinal microbiota was assessed at Visits 1 and 3 based on 16S rRNA gene sequencing.
arm group label: Food supplement Standart Zdorovya GASTRO
arm group type: Experimental
description: In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.
intervention type: Dietary Supplement
intervention name: Food Supplement With Standardized Menthol, Limonene, and Ginger
description: Components of Standart Zdorovya GASTRO: Peppermint oil (40% menthol, 1.5% limonene) - 240 mg, Ginger oil (14% gingerol) - 50 mg, olive oil - 440 mg, 1 capsule, 730 mg, once a day for 30 days
arm group label: Food supplement Standart Zdorovya GASTRO
other name: Standart Zdorovya GASTRO
intervention type: Other
intervention name: Placebo
description: Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Federal Stare Budgetary Scientific Institution, Mental Health Research Center
investigator full name: Allan G. Beniashvilia
investigator title: Senior research fellow, PHD
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
mesh term: Constipation
mesh term: Diarrhea
mesh term: Menthol
sharing ipd: No