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

Antibiotic Resistant Infection Clinical Trial

Official title:

Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03535272
• Other study ID #: 7082
• Status: Terminated
• Phase: Phase 3
• Start date: May 20, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 281
• Est. completion date: December 31, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Diarrhea
• Diarrhea Travelers

Intervention

Drug:
• 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.
• Placebo Oral Tablet
Placebo manufactured to mimic pepto bismol

Locations

Country	Name	City	State
United States	Marina Rogova	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Procter and Gamble, The New York Center for Travel and Tropical Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traveler's diarrhea	Self-reported TD	Change from baseline through 10 days post-travel
Secondary	Gut AMR genes	Pre- and post-travel stools will be tested for the presence/absence of AMR	Once within 7 days (before travel); once within 10 days (after travel)