Study Summary
This trial will test whether taking the drug bismuth subsalicylate can prevent travelers' diarrhea or the spread of antibiotic-resistant genes.
- Traveler's Diarrhea
- Antibiotic Resistance
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Once within 7 days (before travel); once within 10 days (after travel)
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Intervention Group
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group
488 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention Group · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 69 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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 ≤" - Anonymous Online Contributor
Are people aged 30 years or more welcome to participate in this clinical trial?
"This trial is open to anyone aged 18-69." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor