← Back to Search

Salicylate

Bismuth Subsalicylate for Traveler's Diarrhea

Phase 3
Waitlist Available
Led By Bradley Connor, MD
Research Sponsored by Centers for Disease Control and Prevention
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be ≥ 18 and <70 years of age at the time of enrollment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once within 7 days (before travel); once within 10 days (after travel)
Awards & highlights

Study Summary

This trial will test whether taking the drug bismuth subsalicylate can prevent travelers' diarrhea or the spread of antibiotic-resistant genes.

Who is the study for?
Adults aged 18-69 planning to travel to certain regions in Asia or Africa for 7-21 days can join this trial. They must be willing to take Bismuth subsalicylate (BSS) or a placebo, provide stool samples, and not use pre/probiotics during the study. Pregnant women, those on conflicting medications like antibiotics within the last month, or with conditions like kidney disease or immune disorders cannot participate.Check my eligibility
What is being tested?
This study tests if taking Bismuth subsalicylate before traveling prevents travelers' diarrhea and affects antibiotic resistance genes in stool. Participants are randomly given either BSS or a placebo without knowing which one they receive (double-blinded).See study design
What are the potential side effects?
Possible side effects of Bismuth subsalicylate include black stools/tongue, nausea, ringing in ears, and constipation. It's generally considered safe but may interact with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once within 7 days (before travel); once within 10 days (after travel)
This trial's timeline: 3 weeks for screening, Varies for treatment, and once within 7 days (before travel); once within 10 days (after travel) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diarrhea
Secondary outcome measures
Gut AMR genes

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention GroupActive Control1 Intervention
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral tablet 4 bid

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionLead Sponsor
875 Previous Clinical Trials
22,477,121 Total Patients Enrolled
Procter and GambleIndustry Sponsor
146 Previous Clinical Trials
76,299 Total Patients Enrolled
The New York Center for Travel and Tropical MedicineOTHER

Media Library

Bismuth subsalicylate (Salicylate) Clinical Trial Eligibility Overview. Trial Name: NCT03535272 — Phase 3
Traveler's Diarrhea Research Study Groups: Intervention Group, Placebo
Traveler's Diarrhea Clinical Trial 2023: Bismuth subsalicylate Highlights & Side Effects. Trial Name: NCT03535272 — Phase 3
Bismuth subsalicylate (Salicylate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03535272 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If I take part in this research, what are the guidelines I would need to follow?

"This study is looking for 488 patients with diarrhea between the ages of 18 and 69. Most notable, applicants must meet the following criteria: Be ≥ 18 and <70 years of age at the time of enrollment, Plan on leaving for an international trip ≥7 days after their pre-travel consultation, Be willing to complete questionnaires and provide biologic specimens (stool) within 7 days of departure and within 10 days after return, Be willing to refrain from taking any pre-biotics, probiotic, synbiotic and/or herbal supplements throughout their study period, Plan on traveling in country for ≥7 days but ≤"

Answered by AI

Are people aged 30 years or more welcome to participate in this clinical trial?

"This trial is open to anyone aged 18-69."

Answered by AI

Is this the first time this sort of experiment has been attempted?

"Intervention Group has been under scientific scrutiny since 2018. The very first clinical study was sponsored by Procter and Gamble and took place that same year. After the trial involving 488 participants, the drug was approved for Phase 3. As of right now, there are two ongoing trials in two different cities and one nation."

Answered by AI

What is the largest amount of people who can be a part of this experiment?

"Yes, that is correct. The clinical trial in question is still recruiting patients, as of February 24th, 2022. This particular study was posted on May 20th, 2018. There are currently 488 patients needed from 2 medical sites."

Answered by AI

Does the FDA sanction Intervention Group's practices?

"Since this is a Phase 3 trial, there is already some evidence of the intervention's efficacy as well as multiple rounds of data supporting its safety. Therefore, the team at Power has rated the safety of Intervention Group as a 3."

Answered by AI

Is the Intervention Group a popular study topic?

"At this moment, there are 2 ongoing trials for the Intervention Group- one of which is in Phase 3. Although a few of the clinical trials are situated in Louisville, Kentucky, there are a total of 3 locations running these sorts of tests."

Answered by AI

To what purpose is Intervention Group most often employed?

"Intervention Group is often used to treat curling ulcer and other conditions like helicobacter pylori infection, diarrhea, and upset stomach."

Answered by AI

Are there currently any patients being sought for this clinical trial?

"Yes, this clinical trial is seeking participants, as reflected on clinicaltrials.gov. This research project was initially posted on May 20th, 2018 and was most recently updated on February 24th, 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
Kristina Angelo 2018. "Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03535272.
~41 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top