NCT01726426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

November 3, 2012

Last Update Submit

May 2, 2014

Conditions

Chronic Arsenic Poisoning

Keywords

Chronic arsenic poisoningPalmer arsenical keratosis

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Arsenic level in stool

    0 week (baseline), 12 weeks (end)

  • Changes in palmer keratosis following supplementation

    0 week (baseline), 12 weeks (end)

Study Arms (3)

Patients of palmer arsenical keratosis

EXPERIMENTAL

Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks

Dietary Supplement: Probiotic

Arsenic exposed controls

ACTIVE COMPARATOR

Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks

Dietary Supplement: Probiotic

Heathy volunteers

ACTIVE COMPARATOR

Probiotics Capsule (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks

Dietary Supplement: Probiotic

Interventions

ProbioticDIETARY_SUPPLEMENT

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

Arsenic exposed controlsHeathy volunteersPatients of palmer arsenical keratosis

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • drinking arsenic safe water \<50 ppb)
  • those voluntarily agreed to participate

You may not qualify if:

  • pregnancy
  • lactating mother
  • patient receiving treatment of arsenicosis
  • any other chronic disease like tuberculosis, diabetes, asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. and Chairman, Department of Pharmacology

Study Record Dates

First Submitted

November 3, 2012

First Posted

November 15, 2012

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

BA(1)