Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

Chronic Arsenic Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726426
• Other study ID #: BSMMU-001-CT
• Status: Completed
• Phase: N/A
• First received: November 3, 2012
• Last updated: May 2, 2014
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arsenic Poisoning
• Chronic Arsenic Poisoning
• Poisoning

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pathogenic anaerobic bacteria in stool	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.	0 weeks (baseline), 12 weeks (end)	No
Secondary	Arsenic level in stool	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.	0 week (baseline), 12 weeks (end)	No
Secondary	Changes in palmer keratosis following supplementation	There will be improvement of moderate palmer keratosis following supplementation with probiotics.	0 week (baseline), 12 weeks (end)	No