CompletedNot Applicable

Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

Bangladesh90 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of pathogenic anaerobic bacteria in stool

Timeframe: 0 weeks (baseline), 12 weeks (end)

Trial details

NCT IDNCT01726426

SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Chronic Arsenic Poisoning trials