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

NCT03535272 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 7082
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Traveler's Diarrhea

  Self-reported TD

  Change from baseline through 10 days post-travel

Secondary Outcomes (1)

• Gut AMR Genes

  Once within 7 days (before travel); once within 10 days (after travel)

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Drug: Bismuth subsalicylate

Placebo

PLACEBO COMPARATOR

Placebo oral tablet 4 bid

Drug: Placebo Oral Tablet

Interventions

Bismuth subsalicylate 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.

Also known as: Pepto Bismol

Intervention Group

Placebo Oral Tablet DRUG

Placebo manufactured to mimic pepto bismol

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥ 18 and \<70 years of age at the time of enrollment
• Sign an informed consent stating willingness to participate and comply with the study protocol
• Plan on leaving for an international trip ≥7 days after their pre-travel consultation
• 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)
• Traveling to either South East Asia, South Central Asia, North Africa, or Sub-Saharan Africa for at least 7 days of their itinerary
• Be willing to complete an initial eligibility screening
• 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

You may not qualify if:

• Are \<18 years of age or \>69 years of age
• Are traveling in country for \<7 or \>21 days
• 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)
• 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
• 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)
• Have taken an antibiotic in the 30 days before departure
• Have taken any medications that may lower one's ability to fight infection (e.g., steroids, monoclonal antibodies, etc.)
• 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
• Have had diarrhea anytime in the previous 30 days, have diarrhea at the pre-travel consultation, or develop diarrhea before departure
• Have been given doxycycline for malaria prophylaxis for the current trip (due to possible drug-drug interactions and decreased absorption of the doxycycline)
• Have an allergy to any component of the placebo tablets

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Procter and Gamble: collaborator
• The New York Center for Travel and Tropical Medicine: collaborator

Study Sites (1)

Marina Rogova

New York, New York, 10022, United States

Location

Related Publications (1)

• Gibb RD, Brum JM, Sloan KJ, Pitz AM, Circello BT, Grayling RA. Revisiting the efficacy of bismuth subsalicylate for the prevention of traveller's diarrhoea. J Travel Med. 2025 Oct 1;32(6):taaf076. doi: 10.1093/jtm/taaf076.

  PMID: 40720752 DERIVED

MeSH Terms

Interventions

bismuth subsalicylate; Dioctyl Sulfosuccinic Acid

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Kristina Angelo
• Organization: Centers for Disease Control and Prevention

kangelo@cdc.gov

404-718-4876

Study Officials

• Bradley Connor, MD

  The New York Center for Travel and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Epidemiologist; Study co-Principal Investigator

Model Details: This study will be conducted as a double-blinded, placebo-controlled randomized clinical trial.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 24, 2018
• Study Start: May 20, 2018
• Primary Completion: November 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 2, 2026
• Results First Posted: March 12, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)