Intervention Group for Traveler's Diarrhea

New York Center for Travel and Tropical Medicine, New York, NY
Traveler's Diarrhea+1 More ConditionsBismuth subsalicylate - Drug
18 - 69
All Sexes
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Traveler's Diarrhea
  • Antibiotic Resistance

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Once within 7 days (before travel); once within 10 days (after travel)

Day 10
Day 10
Gut AMR genes

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Intervention Group
1 of 2
1 of 2

Active Control

Non-Treatment Group

488 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention Group · Has Placebo Group · Phase 3

Intervention Group
ActiveComparator Group · 1 Intervention: Bismuth subsalicylate · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: once within 7 days (before travel); once within 10 days (after travel)

Who is running the clinical trial?

Centers for Disease Control and PreventionLead Sponsor
840 Previous Clinical Trials
21,472,570 Total Patients Enrolled
Procter and GambleIndustry Sponsor
138 Previous Clinical Trials
75,732 Total Patients Enrolled
The New York Center for Travel and Tropical MedicineOTHER
Bradley Connor, MDPrincipal InvestigatorThe New York Center for Travel and Tropical Medicine

Eligibility Criteria

Age 18 - 69 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have plans to travel to certain regions such as Southeast Asia, North Africa, or Sub-Saharan Africa for at least 7 days.
You cannot take pre-biotics, probiotic, synbiotic, or herbal supplements during the study.

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.