Clinical Trial: Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Dates:
Date Received: November 3, 2012
Date Started: April 2013
Date Completion:
Last Updated: May 2, 2014
Last Verified: May 2014