Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Diarrhea Travelers Antibiotic Resistant Infection Drug: Bismuth subsalicylate Drug: Placebo Oral Tablet Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 488 participants
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
Official Title: Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes
Actual Study Start Date : May 20, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention Group
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
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

Placebo Comparator: Placebo
Placebo oral tablet 4 bid
Drug: Placebo Oral Tablet
Placebo manufactured to mimic pepto bismol




Primary Outcome Measures :
  1. Traveler's diarrhea [ Time Frame: Change from baseline through 10 days post-travel ]
    Self-reported TD


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535272


Contacts
Layout table for location contacts
Contact: Olga Whyte 646-859-6112 olgawhytern@gmail.com
Contact: Kristina Angelo, DO, MPH&TM 404-639-7023 kangelo@cdc.gov

Locations
Layout table for location information
United States, New York
New York Center for Travel and Tropical Medicine Recruiting
New York, New York, United States, 10022
Contact: Olga Whyte, RN         
Principal Investigator: Bradley Connor, MD         
Sponsors and Collaborators
Centers for Disease Control and Prevention
Procter and Gamble
New York Center for Travel and Tropical Medicine

Layout table for additonal information
Responsible Party: Kristina Angelo, Medical Epidemiologist; Study co-Principal Investigator, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03535272     History of Changes
Other Study ID Numbers: 7082
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Bismuth
Bismuth subsalicylate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antidiarrheals