Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chronic Arsenic Poisoning	Dietary Supplement: Probiotic	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Modulation of Anaerobic Gut Bacteria in Palmer Arsenical Keratosis Patients by Supplementation With Probiotics
Study Start Date :	April 2013
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	November 15, 2012
Last Update Posted:	May 5, 2014
Last Verified:	May 2014

Keywords provided by Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

Chronic arsenic poisoning; Palmer arsenical keratosis

Additional relevant MeSH terms:

Poisoning; Arsenic Poisoning; Chemically-Induced Disorders	Heavy Metal Poisoning, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases