Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

May 2, 2014 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0 weeks (baseline), 12 weeks (end)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
0 week (baseline), 12 weeks (end)
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.
0 week (baseline), 12 weeks (end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BSMMU-001-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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