Trial Outcomes & Findings for Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea (NCT NCT03535272)
NCT ID: NCT03535272
Last Updated: 2025-03-12
Results Overview
Self-reported TD
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
482 participants
Primary outcome timeframe
Change from baseline through 10 days post-travel
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
Intervention Group
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
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
Placebo oral tablet 4 bid
Placebo Oral Tablet: Placebo manufactured to mimic pepto bismol
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
207
|
|
Overall Study
COMPLETED
|
136
|
134
|
|
Overall Study
NOT COMPLETED
|
71
|
73
|
Reasons for withdrawal
| Measure |
Intervention Group
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
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
Placebo oral tablet 4 bid
Placebo Oral Tablet: Placebo manufactured to mimic pepto bismol
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
71
|
73
|
Baseline Characteristics
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
Baseline characteristics by cohort
| Measure |
Intervention Group
n=136 Participants
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
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
n=134 Participants
Placebo oral tablet 4 bid
Placebo Oral Tablet: Placebo manufactured to mimic pepto bismol
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
32 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
84 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
136 participants
n=5 Participants
|
134 participants
n=7 Participants
|
270 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline through 10 days post-travelSelf-reported TD
Outcome measures
| Measure |
Intervention Group
n=136 Participants
Bismuth subsalicylate 4 tablets po bid (2.1 grams total of BSS)
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
n=134 Participants
Placebo oral tablet 4 bid
Placebo Oral Tablet: Placebo manufactured to mimic pepto bismol
|
|---|---|---|
|
Traveler's Diarrhea
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 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 genes
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kristina Angelo
Centers for Disease Control and Prevention
Phone: 404-718-4876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place