Healthy Adults
Conditions
Keywords
enema
Brief summary
The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.
Interventions
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy * Age 18 to 70 years old * Non-pregnant
Exclusion criteria
* GI complaints * Pregnancy * Patients with previous colonic surgery or current bowel injury or obstruction * Allergies to contrast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient preference, as assessed by questionnaire | Up to 3 hours post-administration |
Countries
United States
Outcome results
None listed