Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
Primary Purpose
Diarrhea Travelers, Antibiotic Resistant Infection
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bismuth subsalicylate
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea Travelers
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Marina RogovaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention Group
Placebo
Arm Description
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
Placebo oral tablet 4 bid
Outcomes
Primary Outcome Measures
Traveler's diarrhea
Self-reported TD
Secondary Outcome Measures
Gut AMR genes
Pre- and post-travel stools will be tested for the presence/absence of AMR
Full Information
NCT ID
NCT03535272
First Posted
May 1, 2018
Last Updated
August 28, 2023
Sponsor
Centers for Disease Control and Prevention
Collaborators
Procter and Gamble, The New York Center for Travel and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03535272
Brief Title
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
Official Title
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Procter and Gamble, The New York Center for Travel and Tropical Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea Travelers, Antibiotic Resistant Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study will be conducted as a double-blinded, placebo-controlled randomized clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
488 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet 4 bid
Intervention Type
Drug
Intervention Name(s)
Bismuth subsalicylate
Other Intervention Name(s)
Pepto Bismol
Intervention Description
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
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo manufactured to mimic pepto bismol
Primary Outcome Measure Information:
Title
Traveler's diarrhea
Description
Self-reported TD
Time Frame
Change from baseline through 10 days post-travel
Secondary Outcome Measure Information:
Title
Gut AMR genes
Description
Pre- and post-travel stools will be tested for the presence/absence of AMR
Time Frame
Once within 7 days (before travel); once within 10 days (after travel)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Rogova
Phone
212-988-2800
Email
mrogova@connormd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Connor, MD
Organizational Affiliation
The New York Center for Travel and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marina Rogova
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Rogova
Phone
212-988-2800
Email
mrogova@connormd.com
First Name & Middle Initial & Last Name & Degree
Bradley Connor, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
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