Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

May 2, 2014 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Modulation of Anaerobic Gut Bacteria in Palmer Arsenical Keratosis Patients by Supplementation With Probiotics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients of palmer arsenical keratosis
Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Dietary supplement: Probiotic
Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Active Comparator: Arsenic exposed controls
Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Dietary supplement: Probiotic
Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Active Comparator: Heathy volunteers
Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Dietary supplement: Probiotic
Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pathogenic anaerobic bacteria in stool
Time Frame: 0 weeks (baseline), 12 weeks (end)
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.
0 weeks (baseline), 12 weeks (end)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arsenic level in stool
Time Frame: 0 week (baseline), 12 weeks (end)
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.
0 week (baseline), 12 weeks (end)
Changes in palmer keratosis following supplementation
Time Frame: 0 week (baseline), 12 weeks (end)
There will be improvement of moderate palmer keratosis following supplementation with probiotics.
0 week (baseline), 12 weeks (end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 3, 2012

First Submitted That Met QC Criteria

November 10, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 5, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU-001-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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