Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea

NCT ID: NCT03535272

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 482 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-20
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this study is to determine if the use of prophylactic bismuth subsalicylate (BSS) has an effect on the acquisition of travelers' diarrhea (TD) or antimicrobial resistance (AMR) genes in fecal samples among international travelers who departed from the United States to South East Asia, South Central Asia, or Africa. Our hypotheses will be tested using a double-blinded, placebo controlled randomized clinical trial with participants from a pre-travel health clinic in the United States.

Conditions

Diarrhea Travelers; Antibiotic Resistant Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group

Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)

Group Type: ACTIVE_COMPARATOR

Bismuth subsalicylate

Intervention Type: DRUG

We aim to determine if there is a biologic benefit to an intervention (BSS administration) in the acquisition of travelers diarrhea and the acquisition of antimicrobial resistance genes.

Placebo

Placebo oral tablet 4 bid

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo manufactured to mimic pepto bismol

Interventions

Bismuth subsalicylate

We aim to determine if there is a biologic benefit to an intervention (BSS administration) in the acquisition of travelers diarrhea and the acquisition of antimicrobial resistance genes.

Intervention Type: DRUG

Placebo Oral Tablet

Placebo manufactured to mimic pepto bismol

Intervention Type: DRUG

Other Intervention Names

Pepto Bismol

Eligibility Criteria

Inclusion Criteria

1. Be ≥ 18 and <70 years of age at the time of enrollment

2. Sign an informed consent stating willingness to participate and comply with the study protocol

3. Plan on leaving for an international trip ≥7 days after their pre-travel consultation

4. Plan on traveling in country for ≥7 days but ≤21 days (21 day limit due to BSS duration recommendations and a lack of data on longer-term BSS use)

5. Traveling to either South East Asia, South Central Asia, North Africa, or Sub-Saharan Africa for at least 7 days of their itinerary

6. Be willing to complete an initial eligibility screening

7. Be willing to complete questionnaires and provide biologic specimens (stool) within 7 days of departure and within 10 days after return

8. Be willing to refrain from taking any pre-biotics, probiotic, synbiotic and/or herbal supplements throughout their study period

Exclusion Criteria

1. Are <18 years of age or >69 years of age

2. Are traveling in country for <7 or >21 days

3. Have known or suspected contraindications to taking BSS (including, but not limited to, travelers with kidney disease, diabetes, gout, a clotting disorder, or an allergy to any component of BSS)

4. Are pregnant (via self-report), are planning to become pregnant, or may become pregnant during travel (not actively using contraception and are sexually active), or are breastfeeding

5. Routinely take a medication known to interact with BSS (including, but not limited to, insulin, methotrexate, valproic acid, angiotensin-converting enzyme inhibitors, anticoagulants, or other salicylates)

6. Have taken an antibiotic in the 30 days before departure

7. Have taken any medications that may lower one's ability to fight infection (e.g., steroids, monoclonal antibodies, etc.)

8. Have previous diagnoses of immunocompromising conditions such as HIV/AIDS, complement deficiency, immunoglobulin deficiency, or undergoing active chemotherapy or participants with chronic gastrointestinal disorders, such as chronic diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), celiac disease, malabsorption syndromes, pancreatic insufficiency, gallbladder disease, or current gastrointestinal cancer

9. Have had diarrhea anytime in the previous 30 days, have diarrhea at the pre-travel consultation, or develop diarrhea before departure

10. Have been given doxycycline for malaria prophylaxis for the current trip (due to possible drug-drug interactions and decreased absorption of the doxycycline)

11. Have an allergy to any component of the placebo tablets

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

The New York Center for Travel and Tropical Medicine

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Kristina Angelo

Medical Epidemiologist; Study co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bradley Connor, MD

Role: PRINCIPAL_INVESTIGATOR

The New York Center for Travel and Tropical Medicine

Locations

Marina Rogova

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

7082

Identifier Type: -

Identifier Source: org_study_id