ArticleEClinicalMedicine2026
Enterotoxigenic
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04605783 (A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate A Dietary Supplement to Maintain Gut Health During Deployment and Travel), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate A Dietary Supplement to Maintain Gut Health During Deployment and Travel
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0 citing papers in PubMed.
No citing paper in PubMed yet.
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Enterotoxigenic Methods: In this randomised, double-blind, placebo-controlled superiority trial, US and UK military personnel and adult civilians (aged 18-70 years) travelling to TD-risk regions were randomised (1:1) to receive ETEC HBC (600 mg twice daily) or placebo, starting 2 days before arrival and continuing for 10-20 days while in the risk area. The primary outcome was TD, defined by standardised criteria. Stool smears collected during diarrhoeal episodes and at the end-of-prophylaxis were tested by PCR for pathogen attribution. ETEC-attributable TD was assessed as a secondary outcome. This trial is registered with ClinicalTrials.gov, NCT04605783 and is complete. Findings: Between June 2, 2022, and April 29, 2025, 975 participants were enrolled and 850 were randomised to ETEC HBC (n = 425) or placebo (n = 425). Of these, 317 ETEC HBC and 323 placebo recipients were included in the primary efficacy analysis. TD occurred in 22.7% of ETEC HBC and 26.3% of placebo recipients (relative protective efficacy [PE] 13.7 [95% CI -13.4 to 34.31]), below the protocol-specified efficacy threshold of ≥35%. ETEC accounted for 17% of attributable TD cases, with frequent multi-organism detections. The difference in ETEC attributable TD between the groups was not statistically significant (12.1 vs. 21.5%; PE: 43.8 [-28.5 to 75.4]). Adverse events were rare and mild (ETEC HBC 2/320 vs. placebo 2/325). Both events in the ETEC HBC group (frequent urination, hives) resolved spontaneously. Interpretation: ETEC HBC did not significantly reduce overall TD risk, with interpretation of ETEC-specific efficacy constrained by limited power. Further research is warranted to determine whether broader ETEC antigenic coverage or multi-pathogen approaches can overcome the pathogen diversity and polymicrobial infections observed in field settings. Funding: Defense Health Agency.
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