Chronic Diarrhea
Conditions
Keywords
Diarrhea, Gastrointestinal transit
Brief summary
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
Detailed description
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.
Interventions
DRUGOpium tincture
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
DRUGPlacebo
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
Sponsors
Aarhus University Hospital
Asbjørn Mohr Drewes
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Signed informed consent before any study specific procedures * Able to read and understand Danish * Male or female with an age of 20 years or more * The researcher believes that the participant understands what the study entails, are capable of following instructions, can attend when needed, and are expected to complete the study. * The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study. * Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide has failed. OR * No specific underlying pathophysiology has been identified and treatment with loperamide has failed. * At least 6 months post-surgery in the gastrointestinal tract * No sign of cancer at standard clinical follow-up * Chronic diarrhea defined as at least 3 daily bowel movements for the last week
Exclusion criteria
* • Known allergy towards pharmaceutical compounds similar to Dropizol. * Participation in other studies within 14 days of first visit (1 year if opioids involved). * Expected need of medical/surgical treatment during the study * History of psychiatric illness (e.g. mental retardation, schizophrenia, major depression) * History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulants and/or opioids) * Family history of substance abuse * Known major stenosis of the intestines * Known severe decreased renal function (defined as eGFR below 30) * Known severe decreased hepatic function (defined as Child-Pugh class B or higher) * Treatment with MAO- inhibitors during the entity of the study * Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation) * Known cor pulmonale * Female participants that are lactating * Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study * Treatment with opium tincture during the last month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel movement frequency | From day 1 to 7 | Difference in number of spontaneous bowel movements per day between arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency | From day 1 to 7 in each study period | Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7) |
| Pupil diameter | Day 1, 4 and 7 in each study period | Measured in mm |
| General cognition | Day 1, 4 and 7 in each study period | Evaluated using the Mini-Mental State Examination |
| Gastrointestinal transit | Measurement started on day 4 of each study period until expulsion of the capsule] | Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment |
| Short-term memory | Day 1, 4 and 7 in each study period | Measured as number of digits correctly remembered after visual presentation |
| Gastrointestinal symptoms | Day 1, 4 and 7 in each study period | Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire |
| Constipation symptoms | Day 1, 4 and 7 in each study period | Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire |
| Reaction time | Day 1, 4 and 7 in each study period | Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button |
Countries
Denmark
Outcome results
None listed