The purpose of this study is to investigate the mechanistic anti-propulsive effects of opium tincture on the gastrointestinal tract of a cohort of patients with chronic diarrhea
Opium tincture is used a symptomatic drug against chronic diarrhea even though no clinical studies have investigated the effect on gastrointestinal function. With this randomized, double-blind, placebo-controlled cross-over trial in 16 patients with chronic diarrhea, we wish to provide evidence-based insights into the effects of opium tincture on gastrointestinal function. Additionally, effects on the central nervous system will be investigated a tertiary aim.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
Self-administration of opium tincture (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period
Self-administration of placebo (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period
Aalborg University Hospital
Aalborg, Denmark
Aarhus University hospital
Aarhus, Denmark
Bowel movement frequency
Difference in number of spontaneous bowel movements per day between arms
Time frame: From day 1 to 7
Gastrointestinal transit
Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment
Time frame: Measurement started on day 4 of each study period until expulsion of the capsule]
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7)
Time frame: From day 1 to 7 in each study period
Pupil diameter
Measured in mm
Time frame: Day 1, 4 and 7 in each study period
General cognition
Evaluated using the Mini-Mental State Examination
Time frame: Day 1, 4 and 7 in each study period
Reaction time
Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button
Time frame: Day 1, 4 and 7 in each study period
Short-term memory
Measured as number of digits correctly remembered after visual presentation
Time frame: Day 1, 4 and 7 in each study period
Gastrointestinal symptoms
Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire
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Time frame: Day 1, 4 and 7 in each study period
Constipation symptoms
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
Time frame: Day 1, 4 and 7 in each study period