Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics
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ClinicalTrials.gov Identifier: NCT01726426 |
Recruitment Status
:
Completed
First Posted
: November 15, 2012
Last Update Posted
: May 5, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Arsenic Poisoning | Dietary Supplement: Probiotic | Not Applicable |
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 |

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
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Dietary Supplement: Probiotic
Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
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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
|
- 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.
- 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.

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726426
Bangladesh | |
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University | |
Dhaka, Bangladesh, 1000 |
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 Key Record Dates |
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 |