<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/NCT04447443</url>
  </required_header>
  <id_info>
    <org_study_id>2019-111</org_study_id>
    <nct_id>NCT04447443</nct_id>
  </id_info>
  <brief_title>Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors</brief_title>
  <official_title>Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinhua Municipal Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quzhou Kecheng People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
      This study evaluates longitudinal data associating changes in gut microbiota composition and&#xD;
      diversity, defecation, performance status and adverse reactions in response to prebiotic&#xD;
      fiber supplementation in patients with gastrointestinal cancer chemotherapy-related diarrhea.&#xD;
      120 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm&#xD;
      A (intervention group) will receive prebiotic fiber and loperamide hydrochloride capsule(a&#xD;
      drug for standard treatment). Arm B will receive maltodextrin placebo and loperamide&#xD;
      hydrochloride capsule.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    discontinued prematurely by sponsor for strategic reasons&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 30, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea</measure>
    <time_frame>2 weeks</time_frame>
    <description>Numbers of bowel movements per day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>onset time</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 weeks</time_frame>
    <description>Incidence of mild (e.g. self-resolving), moderate (e.g. those that warrant medical evaluation and treatment) and serious (e.g. those that cannot be resolved by medical treatment) adverse events based on criteria adopted by the National Institute of Health common terminology criteria for adverse events (NIH severity) will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changs in Karnofsky Performance Status</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota changes in response to intervention</measure>
    <time_frame>Change from baseline in gut microbiota at 1 and 2 weeks ]</time_frame>
    <description>16S rRNA sequencing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chemotherapy-related Diarrhea</condition>
  <arm_group>
    <arm_group_label>Prebiotic Fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Prebiotic Fiber Supplement + loperamide hydrochloride capsule</intervention_name>
    <description>2-week sequential supplementation with prebiotic fiber supplement (3.5g, twice a day).&#xD;
The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.</description>
    <arm_group_label>Prebiotic Fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin + loperamide hydrochloride capsule</intervention_name>
    <description>2-week sequential supplementation with placebo of of maltodextrin (3.5g, twice a day).&#xD;
The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.</description>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65, be able to comply with the protocol&#xD;
&#xD;
          -  Life expectancy greater than 3 months&#xD;
&#xD;
          -  Patients with cytologically or histologically confirmed diagnosis of gastrointestinal&#xD;
             cancers&#xD;
&#xD;
          -  Undergoing chemotherapy, not synchronized with radiotherapy and other anti-tumor&#xD;
             treatments&#xD;
&#xD;
          -  Chemotherapy-related diarrhea grade 2-4&#xD;
&#xD;
          -  Not experience diarrhea before chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18 or &gt;65&#xD;
&#xD;
          -  Patients who cannot eat by mouth for example chewing disorders, difficulty swallowing,&#xD;
             intractable vomiting, gastrointestinal obstruction or gastrointestinal tract bleeding&#xD;
&#xD;
          -  Other acute or chronic diarrhea or colostomy&#xD;
&#xD;
          -  Patients with other severe adverse effects of chemotherapy other than diarrhea&#xD;
&#xD;
          -  Patients with severe diseases of heart, kidney, liver and other major organs&#xD;
&#xD;
          -  Use of any other drug for promoting intestine movement&#xD;
&#xD;
          -  Use of any other drug or dietary supplement for chemotherapy-related diarrhea such as&#xD;
             other fiber supplements, probiotics, octreotide&#xD;
&#xD;
          -  Allergic to the components of the intervention dietary supplements;&#xD;
&#xD;
          -  Pregnancy (positive serum pregnancy test) and lactation&#xD;
&#xD;
          -  Any other serious or uncontrolled illness which the investigator think is undesirable&#xD;
             for the patient to enter the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pianhong Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, Zhejiang University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Second Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 1, 2021</last_update_submitted>
  <last_update_submitted_qc>August 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</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>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loperamide</mesh_term>
    <mesh_term>Antidiarrheals</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04447443
org study id: 2019-111
nct id: NCT04447443
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates longitudinal data associating changes in gut microbiota composition and
      diversity, defecation, performance status and adverse reactions in response to prebiotic
      fiber supplementation in patients with gastrointestinal cancer chemotherapy-related diarrhea.
      120 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm
      A (intervention group) will receive prebiotic fiber and loperamide hydrochloride capsule(a
      drug for standard treatment). Arm B will receive maltodextrin placebo and loperamide
      hydrochloride capsule.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
time frame: 2 weeks
description: Numbers of bowel movements per day
measure: onset time
time frame: 2 weeks
measure: Adverse events
time frame: 2 weeks
description: Incidence of mild (e.g. self-resolving), moderate (e.g. those that warrant medical evaluation and treatment) and serious (e.g. those that cannot be resolved by medical treatment) adverse events based on criteria adopted by the National Institute of Health common terminology criteria for adverse events (NIH severity) will be evaluated
measure: Changs in Karnofsky Performance Status
time frame: 2 weeks
measure: Gut microbiota changes in response to intervention
time frame: Change from baseline in gut microbiota at 1 and 2 weeks ]
description: 16S rRNA sequencing
arm group label: Prebiotic Fiber
arm group type: Experimental
arm group label: Maltodextrin
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Prebiotic Fiber Supplement + loperamide hydrochloride capsule
description: 2-week sequential supplementation with prebiotic fiber supplement (3.5g, twice a day).
The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.
arm group label: Prebiotic Fiber
intervention type: Dietary Supplement
intervention name: Maltodextrin + loperamide hydrochloride capsule
description: 2-week sequential supplementation with placebo of of maltodextrin (3.5g, twice a day).
The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.
arm group label: Maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pianhong Zhang
role: Principal Investigator
affiliation: Second Affiliated Hospital, Zhejiang University School of Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Diarrhea
mesh term: Loperamide
mesh term: Antidiarrheals
sharing ipd: Undecided