<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/NCT01706393</url>
  </required_header>
  <id_info>
    <org_study_id>SNUH-Cell-01</org_study_id>
    <nct_id>NCT01706393</nct_id>
  </id_info>
  <brief_title>Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)</brief_title>
  <acronym>RTxIMprobio</acronym>
  <official_title>Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of probiotics to improve the intestinal&#xD;
      microbiome in malignancy patients who get pelvic/abdominal radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include&#xD;
      diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates&#xD;
      changes in bacterial microbiome, the vascular permeability of the mucosal cells and in&#xD;
      intestinal motility. Probiotics were known to improve gastrointestinal function. This is a&#xD;
      randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate&#xD;
      the effect of probiotics to change the intestinal microbiome in in patients undergoing&#xD;
      concurrent pelvic/abdominal RT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.</measure>
    <time_frame>42 days</time_frame>
    <description>Comparison of overall microbial communities in fecal samples between probiotics treated patients and control cancer patients receiving radiation therapy.&#xD;
To determine preventing effect of probiotics against radiation enteropathy, all the bacterial species level taxon derived from fecal samples of cancer patients will be identified by massive sequencing analysis and relative abundance of each taxon between two groups will be statistically compared.&#xD;
In addition, overall microbial composition, kind of species and their abundance, in two groups will be compared with clustering method such as UPGMA and PCoA and the variation values between two groups will be calculated.&#xD;
In the current study, we will determine the effectiveness of probiotics for the prevention of radiation induced complications with these two comparative analysis methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevention of any grade of diarrhea and gastrointestinal symptoms</measure>
    <time_frame>42 days</time_frame>
    <description>Gastrointestinal symptoms will be scored according the Gastrointestinal symptom rating scale before and after RTx.&#xD;
Diarrhea will be graded weekly according the Common Toxicity Criteria system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>probiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Probiotics supplementation group. Probiotics intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.&#xD;
Probiotics is composed of Lactobacillus acidophilus, Streptococcus thermophilus, Bifidobacterium lactis, L. rhamnosus, B. longum and B. bifidum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group. Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.&#xD;
Placebo is composed of starch.Probiotics and placebo were similar in appearance, taste.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>probiotics (six probiotic cultures)</intervention_name>
    <description>Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.</description>
    <arm_group_label>probiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who current diagnosis of gynecologic cancer or rectal cancer and never&#xD;
             previously received radiation therapy and will use for the first time radiotherapy at&#xD;
             department of radiation oncology, Seoul National University Hospital.&#xD;
&#xD;
          -  ECOG performance status (PS) of 0, 1, or 2.&#xD;
&#xD;
          -  signed written informed consent.&#xD;
&#xD;
          -  Patients who get pelvic/abdominal radiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who use antibiotics that can affect intestinal microorganism growth within one&#xD;
             month before the study.&#xD;
&#xD;
          -  Patients who use probiotics within one month before the study.&#xD;
&#xD;
          -  Patients received neoadjuvant chemotherapy.&#xD;
&#xD;
          -  Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient.&#xD;
&#xD;
          -  Patients diagnosed with inflammatory bowel disease.&#xD;
&#xD;
          -  Patients suspected gastrointestinal infections and other infectious diseases.&#xD;
&#xD;
          -  Suspected infections from blood tests : Excessive rise in WBC, ESR, CRP&#xD;
&#xD;
          -  Suspected renal insufficiency from blood tests&#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>Hak Jae Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hak Jae Kim, MD</last_name>
    <phone>+82-2-2072-2520</phone>
    <email>khjae@snu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Seung Wan Kang, MD,PhD</last_name>
    <phone>+82-2-747-7422</phone>
    <email>drdemian@snu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>April 18, 2013</last_update_submitted>
  <last_update_submitted_qc>April 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>probiotics</keyword>
  <keyword>intestinal microbiome</keyword>
  <keyword>radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_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/NCT01706393
org study id: SNUH-Cell-01
nct id: NCT01706393
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of probiotics to improve the intestinal
      microbiome in malignancy patients who get pelvic/abdominal radiotherapy.
Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include
      diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates
      changes in bacterial microbiome, the vascular permeability of the mucosal cells and in
      intestinal motility. Probiotics were known to improve gastrointestinal function. This is a
      randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate
      the effect of probiotics to change the intestinal microbiome in in patients undergoing
      concurrent pelvic/abdominal RT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.
time frame: 42 days
description: Comparison of overall microbial communities in fecal samples between probiotics treated patients and control cancer patients receiving radiation therapy.
To determine preventing effect of probiotics against radiation enteropathy, all the bacterial species level taxon derived from fecal samples of cancer patients will be identified by massive sequencing analysis and relative abundance of each taxon between two groups will be statistically compared.
In addition, overall microbial composition, kind of species and their abundance, in two groups will be compared with clustering method such as UPGMA and PCoA and the variation values between two groups will be calculated.
In the current study, we will determine the effectiveness of probiotics for the prevention of radiation induced complications with these two comparative analysis methods.
measure: Prevention of any grade of diarrhea and gastrointestinal symptoms
time frame: 42 days
description: Gastrointestinal symptoms will be scored according the Gastrointestinal symptom rating scale before and after RTx.
Diarrhea will be graded weekly according the Common Toxicity Criteria system.
arm group label: probiotics
arm group type: Experimental
description: Probiotics supplementation group. Probiotics intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.
Probiotics is composed of Lactobacillus acidophilus, Streptococcus thermophilus, Bifidobacterium lactis, L. rhamnosus, B. longum and B. bifidum.
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo group. Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.
Placebo is composed of starch.Probiotics and placebo were similar in appearance, taste.
intervention type: Dietary Supplement
intervention name: probiotics (six probiotic cultures)
description: Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.
arm group label: probiotics
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hak Jae Kim, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Hak Jae Kim, MD
phone: +82-2-2072-2520
email: khjae@snu.ac.kr
last name: Seung Wan Kang, MD,PhD
phone: +82-2-747-7422
email: drdemian@snu.ac.kr
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neoplasms