Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics - Full Text View

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:

MedlinePlus related topics: Arsenic Poisoning

Genetic and Rare Diseases Information Center resources: Tylosis Heavy Metal Poisoning Neurotoxicity Syndromes

U.S. FDA Resources

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.


Enrollment:	90
Study Start Date:	April 2013
Study Completion Date:	December 2013
Primary Completion Date:	December 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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726426

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


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:	May 2, 2014
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 Chemically-Induced Disorders	Heavy Metal Poisoning, Nervous System Neurotoxicity Syndromes Nervous System Diseases

ClinicalTrials.gov processed this record on September 26, 2016