DiarrheaNCT02047162
Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
A study testing Bismuth subsalicylate in people with Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Pakistan.
Trial summary
The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Bismuth subsalicylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- May 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan
The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.
- Conditions
- Diarrhea
- Being tested
- Bismuth subsalicylate, Placebo
- Keywords
- diarrhea, gastroenteritis, antimicrobial drug resistance, antimicrobial agents, Pakistan, ambulatory care, bismuth
- Medical subject headings
- Diarrhea, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth subsalicylateDrug
Also called Pepto-Bismol
PlaceboOther
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate
| Study group | Role | What they receive |
|---|---|---|
| Bismuth subsalicylate | Experimental | Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours. Receives: Drug: Bismuth subsalicylate |
| Placebo | Placebo comparator | Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of antimicrobial medications
Measured: within 5 days of enrollment
Secondary outcomes (5)
Patient's perceived need for antibiotics
Measured: Within 48 h of enrollment
additional care obtained for diarrhea
Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness
Measured: within 48 h of enrollment
Additional care obtained for diarrheal illness
Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness
Measured: within 5 days of enrollment
Disease severity and duration
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
Measured: within 5 days of enrollment
Patient experience with the study drug
- Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects
Measured: within 5 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Procter and Gamble, Health Oriented Preventive Education
- Responsible party
- Principal investigator, Anna Bowen, Centers for Disease Control and Prevention
- Investigators
- Anna Bowen, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047162
- Sponsor's protocol ID
- 6469
- Status last verified
- Jan 2019
- First submitted
- 24 Jan 2014
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bowen A, Agboatwalla M, Pitz A, Salahuddin S, Brum J, Plikaytis B. Effect of Bismuth Subsalicylate vs Placebo on Use of Antibiotics Among Adult Outpatients With Diarrhea in Pakistan: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199441. doi: 10.1001/jamanetworkopen.2019.9441.
PubMed 31418805
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan
- ClinicalTrials.gov ID
- NCT02047162
- Acronym / sponsor ID
- 6469
- Conditions
- Diarrhea
- Keywords
- diarrhea, gastroenteritis, antimicrobial drug resistance, antimicrobial agents, Pakistan, ambulatory care, bismuth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Procter and Gamble, Health Oriented Preventive Education
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bismuth subsalicylate | Experimental | Drug: Bismuth subsalicylateBismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Is pregnant
- Requires hospitalization
- Has signs or symptoms of septicemia
- Has a primary complaint of another acute illness
- Has a serious chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bismuth subsalicylateAlso: Pepto-Bismol | Drug | Bismuth subsalicylate |
| PlaceboChewable tablets identical to intervention tablets, but missing the bismuth subsalicylate | Other | Placebo |
Primary outcome
use of antimicrobial medications
Time frame: within 5 days of enrollment
5 secondary outcomes
Patient's perceived need for antibiotics
Time frame: Within 48 h of enrollment
additional care obtained for diarrhea
Time frame: within 48 h of enrollment
Additional care obtained for diarrheal illness
Time frame: within 5 days of enrollment
Disease severity and duration
Time frame: within 5 days of enrollment
Patient experience with the study drug
Time frame: within 5 days of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 31418805Bowen A, Agboatwalla M, Pitz A, Salahuddin S, Brum J, Plikaytis B. Effect of Bismuth Subsalicylate vs Placebo on Use of Antibiotics Among Adult Outpatients With Diarrhea in Pakistan: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199441. doi: 10.1001/jamanetworkopen.2019.9441.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Bowen, MD, MPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bismuth subsalicylate in people with Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of antimicrobial medications (time frame: within 5 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02047162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.