Trial record 11 of 282 for:    Open Studies | "Poisoning"

Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

This study is currently recruiting participants.
Verified April 2013 by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor:
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01726426
First received: November 3, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Chronic Arsenic Poisoning
Dietary Supplement: Probiotic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modulation of Anaerobic Gut Bacteria in Palmer Arsenical Keratosis Patients by Supplementation With Probiotics

Resource links provided by NLM:


Further study details as provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Number of pathogenic anaerobic bacteria in stool [ Time Frame: 0 weeks (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    There will be improvement of moderate palmer keratosis following supplementation with probiotics.


Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726426

Contacts
Contact: Mir Misbahuddin, MBBS, PhD 8801552639504 misbah@bdjpharmacol.com

Locations
Bangladesh
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University Recruiting
Dhaka, Bangladesh, 1000
Contact: Mir Misbahuddin, MBBS, PhD    8801552639504    misbah@bdjpharmacol.com   
Principal Investigator: Mir Misbahuddin, MBBS, PhD         
Sub-Investigator: Mohammed Ashraf Ahmed, MBBS         
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  More Information

No publications provided

Responsible Party: Prof. Mir Misbahuddin, Prof. and Chairman, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01726426     History of Changes
Other Study ID Numbers: BSMMU-001-CT
Study First Received: November 3, 2012
Last Updated: April 24, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Chronic arsenic poisoning
Palmer arsenical keratosis

Additional relevant MeSH terms:
Poisoning
Arsenic Poisoning
Substance-Related Disorders
Heavy Metal Poisoning, Nervous System
Neurotoxicity Syndromes
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014