Diarrhea
Conditions
Keywords
diarrhea, gastroenteritis, antimicrobial drug resistance, antimicrobial agents, Pakistan, ambulatory care, bismuth
Brief summary
The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.
Interventions
OTHERPlacebo
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate
Sponsors
Procter and Gamble
Health Oriented Preventive Education
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| use of antimicrobial medications | within 5 days of enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's perceived need for antibiotics | Within 48 h of enrollment | — |
| additional care obtained for diarrhea | 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 |
| Additional care obtained for diarrheal illness | 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 |
| Disease severity and duration | 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 |
| Patient experience with the study drug | within 5 days of enrollment | i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects |
Countries
Pakistan
Outcome results
None listed