<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/NCT01726426</url>
  </required_header>
  <id_info>
    <org_study_id>BSMMU-001-CT</org_study_id>
    <nct_id>NCT01726426</nct_id>
  </id_info>
  <brief_title>Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics</brief_title>
  <official_title>Modulation of Anaerobic Gut Bacteria in Palmer Arsenical Keratosis Patients by Supplementation With Probiotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not&#xD;
      known. This can be evaluated by administering probiotics. Thirty patients from an arsenic&#xD;
      affected area will be provided two probiotics capsules per day orally for 12 weeks and stool&#xD;
      samples will be collected for qualitative and quantitative analysis of anaerobic bacteria.&#xD;
      Similar number of arsenic exposed controls and healthy volunteers from the same area will be&#xD;
      included with similar protocol for comparison. Like aerobic bacteria, anaerobic bacteria may&#xD;
      be modulated by probiotics in arsenicosis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent study done by our laboratory shows that there are reduction in the number of E. coli&#xD;
      in the gut of patients with arsenical keratosis which is increase by the administration of&#xD;
      probiotics (manuscript is preparing). However, E.coli contribute only about 0.1% of the total&#xD;
      gut bacteria. It is not known whether anaerobic bacteria play an important role in the&#xD;
      pathogenesis of arsenical keratosis. This can be evaluated by administering probiotics.&#xD;
      Thirty patients of moderate arsenical palmer keratosis from an arsenic affected area will be&#xD;
      recruited on the basis of inclusion and exclusion criteria. They will be provided two&#xD;
      probiotics capsules per day orally for 12 weeks. Water sample will be collected before&#xD;
      starting the study for confirming the diagnosis. Stool samples will be collected twice&#xD;
      (before and after completion of the study) for qualitative and quantitative analysis of&#xD;
      anaerobic bacteria. Similar number of arsenic exposed controls (30) and healthy volunteers&#xD;
      (30) from the same area will be included in this study and they will be provided probiotics&#xD;
      capsules with similar dosage and duration. Like aerobic bacteria, anaerobic bacteria may be&#xD;
      modulated by probiotics in arsenicosis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of pathogenic anaerobic bacteria in stool</measure>
    <time_frame>0 weeks (baseline), 12 weeks (end)</time_frame>
    <description>Number of pathogenic anaerobic bacteria in the stool of patients will be decrease in comparison to arsenic exposed controls and volunteers after 12 weeks supplementation with probiotics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arsenic level in stool</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>Arsenic level in the stool of patients will be increased in comparison to arsenic exposed controls and healthy volunteers. Arsenic level will be estimated using Atomic Fluorescence spectrometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in palmer keratosis following supplementation</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>There will be improvement of moderate palmer keratosis following supplementation with probiotics.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Chronic Arsenic Poisoning</condition>
  <arm_group>
    <arm_group_label>Patients of palmer arsenical keratosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arsenic exposed controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heathy volunteers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks</description>
    <arm_group_label>Arsenic exposed controls</arm_group_label>
    <arm_group_label>Heathy volunteers</arm_group_label>
    <arm_group_label>Patients of palmer arsenical keratosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Patients):&#xD;
&#xD;
          -  history of taking arsenic contaminated water (&gt;50 ppb) for more than 6 months&#xD;
&#xD;
          -  patients having moderate arsenical keratosis present on palm of the hand&#xD;
&#xD;
          -  patients those voluntarily agree to participate&#xD;
&#xD;
        Inclusion Criteria (Arsenic exposed controls):&#xD;
&#xD;
          -  family member of the patient&#xD;
&#xD;
          -  drinking arsenic contaminated water from the same source as patient&#xD;
&#xD;
          -  those voluntarily agreed to participate&#xD;
&#xD;
          -  no sign/symptoms of palmer keratosis&#xD;
&#xD;
        Inclusion Criteria (Healthy volunteers):&#xD;
&#xD;
          -  drinking arsenic safe water &lt;50 ppb)&#xD;
&#xD;
          -  those voluntarily agreed to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactating mother&#xD;
&#xD;
          -  patient receiving treatment of arsenicosis&#xD;
&#xD;
          -  any other chronic disease like tuberculosis, diabetes, asthma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University</name>
      <address>
        <city>Dhaka</city>
        <zip>1000</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>May 2, 2014</last_update_submitted>
  <last_update_submitted_qc>May 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>Prof. Mir Misbahuddin</investigator_full_name>
    <investigator_title>Prof. and Chairman, Department of Pharmacology</investigator_title>
  </responsible_party>
  <keyword>Chronic arsenic poisoning</keyword>
  <keyword>Palmer arsenical keratosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arsenic Poisoning</mesh_term>
    <mesh_term>Poisoning</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/NCT01726426
org study id: BSMMU-001-CT
nct id: NCT01726426
lead sponsor: 
has dmc: No
The role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not
      known. This can be evaluated by administering probiotics. Thirty patients from an arsenic
      affected area will be provided two probiotics capsules per day orally for 12 weeks and stool
      samples will be collected for qualitative and quantitative analysis of anaerobic bacteria.
      Similar number of arsenic exposed controls and healthy volunteers from the same area will be
      included with similar protocol for comparison. Like aerobic bacteria, anaerobic bacteria may
      be modulated by probiotics in arsenicosis patients.
Recent study done by our laboratory shows that there are reduction in the number of E. coli
      in the gut of patients with arsenical keratosis which is increase by the administration of
      probiotics (manuscript is preparing). However, E.coli contribute only about 0.1% of the total
      gut bacteria. It is not known whether anaerobic bacteria play an important role in the
      pathogenesis of arsenical keratosis. This can be evaluated by administering probiotics.
      Thirty patients of moderate arsenical palmer keratosis from an arsenic affected area will be
      recruited on the basis of inclusion and exclusion criteria. They will be provided two
      probiotics capsules per day orally for 12 weeks. Water sample will be collected before
      starting the study for confirming the diagnosis. Stool samples will be collected twice
      (before and after completion of the study) for qualitative and quantitative analysis of
      anaerobic bacteria. Similar number of arsenic exposed controls (30) and healthy volunteers
      (30) from the same area will be included in this study and they will be provided probiotics
      capsules with similar dosage and duration. Like aerobic bacteria, anaerobic bacteria may be
      modulated by probiotics in arsenicosis patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of pathogenic anaerobic bacteria in stool
time frame: 0 weeks (baseline), 12 weeks (end)
description: Number of pathogenic anaerobic bacteria in the stool of patients will be decrease in comparison to arsenic exposed controls and volunteers after 12 weeks supplementation with probiotics.
measure: Arsenic level in stool
time frame: 0 week (baseline), 12 weeks (end)
description: Arsenic level in the stool of patients will be increased in comparison to arsenic exposed controls and healthy volunteers. Arsenic level will be estimated using Atomic Fluorescence spectrometer.
measure: Changes in palmer keratosis following supplementation
time frame: 0 week (baseline), 12 weeks (end)
description: There will be improvement of moderate palmer keratosis following supplementation with probiotics.
arm group label: Patients of palmer arsenical keratosis
arm group type: Experimental
description: Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
arm group label: Arsenic exposed controls
arm group type: Active Comparator
description: Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
arm group label: Heathy volunteers
arm group type: Active Comparator
description: Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
intervention type: Dietary Supplement
intervention name: Probiotic
description: Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
arm group label: Arsenic exposed controls
arm group label: Heathy volunteers
arm group label: Patients of palmer arsenical keratosis
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Prof. Mir Misbahuddin
investigator title: Prof. and Chairman, Department of Pharmacology
mesh term: Arsenic Poisoning
mesh term: Poisoning