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Completed

NCT Number: NCT02047162

Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan

The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.

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Key information

Conditions

Diarrhea Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HOPE

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons aged 15 - 65 years old
  • Presenting with mild to moderate, non-bloody, acute diarrhea (≥3 loose stools/day for <3 days) to participating health care settings
  • For whom the study physicians recommend antimicrobial treatment

Exclusion criteria

  • Is pregnant
  • Requires hospitalization
  • Has signs or symptoms of septicemia
  • Has a primary complaint of another acute illness
  • Has a serious chronic illness
  • Has an allergy to aspirin
  • Has been exposed to antimicrobial or antidiarrheal medications within 72 hours of enrollment
  • Previously enrolled in study

Treatment and study plan

Bismuth Subsalicylate

Drug

Other names: Pepto-Bismol

Placebo

Other

Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate

Primary outcomes

  1. use of antimicrobial medications

    Time frame: within 5 days of enrollment

Secondary outcomes

  1. Patient's perceived need for antibiotics

    Time frame: Within 48 h of enrollment

  2. additional care obtained for diarrhea

    Time frame: within 48 h of enrollment

    Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness

  3. Additional care obtained for diarrheal illness

    Time frame: within 5 days of enrollment

    Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness

  4. Disease severity and duration

    Time frame: within 5 days of enrollment

    Time to first formed stool Number of stools during first 48 h of observation Duration of abdominal pain Duration of nausea Time to resolution of illness (any of the following symptoms: diarrhea, nausea, vomiting, abdominal pain) Severity of all symptoms of illness

  5. Patient experience with the study drug

    Time frame: within 5 days of enrollment

    i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Health Oriented Preventive Education
  • Procter and Gamble

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 28, 2014
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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