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 range20 Years – 60 Years

SexALL

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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

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