Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco
About this trial
This randomized, placebo-controlled crossover trial will test the feasibility and acceptability of using colesevelam in male firefighters with high per- and polyfluoroalkyl substances (PFAS) exposure. This trial will also explore whether colesevelam lowers blood PFAS levels and urine environmental toxicant and mold mycotoxin levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male firefighter, active or retired
California resident
Age 18 or older
English-speaking
Disqualifiers
Gastroparesis or other severe gastrointestinal motility disorders
Bowel obstruction
History of major gastrointestinal tract surgery
Dysphagia or difficulty swallowing (due to tablet size)
Trial design
Design model
Crossover
Treatments tested in this trial
Colesevelam
DrugColesevelam in 625-mg tablets. Participants will take 3 tablets orally, twice daily (total daily dose 3.75 g) for 12 weeks.
Placebo
DrugMatching inert oral tablets designed to mimic colesevelam 625 mg tablets in size, shape, and color, but containing no active pharmaceutical ingredient. Participants will take 3 orally, twice per day for 12 weeks.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Colesevelam firstActive comparator 2 interventions
Group B: Placebo firstPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Retention
Proportion completing all study blood draws after consent
Time frame
Enrollment to Week 272
Adherence to study drug
Proportion taking ≥80% of colesevelam doses
Time frame
Enrollment to Week 273
Adherence to placebo
Proportion taking ≥80% of placebo doses
Time frame
Enrollment to Week 274
Acceptability
Proportion endorsing "likely" or "very likely" to refer a co-worker to the study
Time frame
Week 27Secondary outcomes
1
Serum PFAS Levels
Between-period and within-person changes in serum concentrations of the National Academy of Sciences, Engineering, and Medicine (NASEM)-7 PFAS score (sum of seven PFAS analytes). Higher scores mean higher PFAS levels in the body. Scores range from 0 to an unknown maximum.
Time frame
Baseline (Week 0) to the end of each 12-week intervention period (Weeks 13 and 27)Other outcomes
1
Urine Mold Mycotoxin Levels
Between-period and within-person changes in urine concentrations of mold mycotoxins
Time frame
Baseline (Week 0) to the end of each 12-week intervention period (Weeks 13 and 27)2
Urine Environmental Toxicant Levels
Between-period and within-person changes in urine concentrations of environmental toxicants
Time frame
Baseline (Week 0) to the end of each 12-week intervention period (Weeks 13 and 27)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov