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Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

Primary Purpose

Chronic Arsenic Poisoning

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Probiotic
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Arsenic Poisoning focused on measuring Chronic arsenic poisoning, Palmer arsenical keratosis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (Patients):

  • history of taking arsenic contaminated water (>50 ppb) for more than 6 months
  • patients having moderate arsenical keratosis present on palm of the hand
  • patients those voluntarily agree to participate

Inclusion Criteria (Arsenic exposed controls):

  • family member of the patient
  • drinking arsenic contaminated water from the same source as patient
  • those voluntarily agreed to participate
  • no sign/symptoms of palmer keratosis

Inclusion Criteria (Healthy volunteers):

  • drinking arsenic safe water <50 ppb)
  • those voluntarily agreed to participate

Exclusion Criteria:

  • pregnancy
  • lactating mother
  • patient receiving treatment of arsenicosis
  • any other chronic disease like tuberculosis, diabetes, asthma

Sites / Locations

  • Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Patients of palmer arsenical keratosis

Arsenic exposed controls

Heathy volunteers

Arm Description

Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks

Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks

Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks

Outcomes

Primary Outcome Measures

Number of pathogenic anaerobic bacteria in stool
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.

Secondary Outcome Measures

Arsenic level in stool
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.
Changes in palmer keratosis following supplementation
There will be improvement of moderate palmer keratosis following supplementation with probiotics.

Full Information

First Posted
November 3, 2012
Last Updated
May 2, 2014
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT01726426
Brief Title
Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics
Official Title
Modulation of Anaerobic Gut Bacteria in Palmer Arsenical Keratosis Patients by Supplementation With Probiotics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Arsenic Poisoning
Keywords
Chronic arsenic poisoning, Palmer arsenical keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients of palmer arsenical keratosis
Arm Type
Experimental
Arm Description
Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Arm Title
Arsenic exposed controls
Arm Type
Active Comparator
Arm Description
Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Arm Title
Heathy volunteers
Arm Type
Active Comparator
Arm 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(s)
Probiotic
Intervention Description
Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Primary Outcome Measure Information:
Title
Number of pathogenic anaerobic bacteria in stool
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.
Time Frame
0 weeks (baseline), 12 weeks (end)
Secondary Outcome Measure Information:
Title
Arsenic level in stool
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.
Time Frame
0 week (baseline), 12 weeks (end)
Title
Changes in palmer keratosis following supplementation
Description
There will be improvement of moderate palmer keratosis following supplementation with probiotics.
Time Frame
0 week (baseline), 12 weeks (end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Patients): history of taking arsenic contaminated water (>50 ppb) for more than 6 months patients having moderate arsenical keratosis present on palm of the hand patients those voluntarily agree to participate Inclusion Criteria (Arsenic exposed controls): family member of the patient drinking arsenic contaminated water from the same source as patient those voluntarily agreed to participate no sign/symptoms of palmer keratosis Inclusion Criteria (Healthy volunteers): drinking arsenic safe water <50 ppb) those voluntarily agreed to participate Exclusion Criteria: pregnancy lactating mother patient receiving treatment of arsenicosis any other chronic disease like tuberculosis, diabetes, asthma
Facility Information:
Facility Name
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh

12. IPD Sharing Statement

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Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

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