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

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ClinicalTrials.gov Identifier: NCT03535272
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Procter and Gamble
New York Center for Travel and Tropical Medicine
Information provided by (Responsible Party):
Kristina Angelo, Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE May 1, 2018
First Posted Date  ICMJE May 24, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE May 20, 2018
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
Traveler's diarrhea [ Time Frame: Change from baseline through 10 days post-travel ]
Self-reported TD
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03535272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
Gut AMR genes [ Time Frame: Once within 7 days (before travel); once within 10 days (after travel) ]
Pre- and post-travel stools will be tested for the presence/absence of AMR
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
Official Title  ICMJE Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will be conducted as a double-blinded, placebo-controlled randomized clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Diarrhea Travelers
  • Antibiotic Resistant Infection
Intervention  ICMJE
  • 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.
    Other Name: Pepto Bismol
  • Drug: Placebo Oral Tablet
    Placebo manufactured to mimic pepto bismol
Study Arms  ICMJE
  • Active Comparator: Intervention Group
    Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
    Intervention: Drug: Bismuth subsalicylate
  • Placebo Comparator: Placebo
    Placebo oral tablet 4 bid
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
488
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Olga Whyte 646-859-6112 olgawhytern@gmail.com
Contact: Kristina Angelo, DO, MPH&TM 404-639-7023 kangelo@cdc.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03535272
Other Study ID Numbers  ICMJE 7082
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kristina Angelo, Centers for Disease Control and Prevention
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE
  • Procter and Gamble
  • New York Center for Travel and Tropical Medicine
Investigators  ICMJE Not Provided
PRS Account Centers for Disease Control and Prevention
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP