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

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ClinicalTrials.gov Identifier: NCT02047162
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : February 4, 2015
Sponsor:
Collaborators:
Procter and Gamble
Health Oriented Preventive Education
Information provided by (Responsible Party):
Anna Bowen, Centers for Disease Control and Prevention

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

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Bismuth subsalicylate Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan
Study Start Date : May 2014
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bismuth subsalicylate
Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours.
Drug: Bismuth subsalicylate
Other Name: Pepto-Bismol
Placebo Comparator: Placebo
Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h.
Other: Placebo
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate



Primary Outcome Measures :
  1. use of antimicrobial medications [ Time Frame: within 5 days of enrollment ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047162


Locations
Pakistan
HOPE
Karachi, Pakistan
Sponsors and Collaborators
Centers for Disease Control and Prevention
Procter and Gamble
Health Oriented Preventive Education
Investigators
Principal Investigator: Anna Bowen, MD, MPH Centers for Disease Control and Prevention

Responsible Party: Anna Bowen, Medical Epidemiologist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02047162     History of Changes
Other Study ID Numbers: 6469
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Anna Bowen, Centers for Disease Control and Prevention:
diarrhea
gastroenteritis
antimicrobial drug resistance
antimicrobial agents
Pakistan
ambulatory care
bismuth

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Infective Agents
Anti-Bacterial Agents
Bismuth
Bismuth subsalicylate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antidiarrheals