Clinical trial NCT05690321: Opium Tincture Against Chronic Diarrhea - Patients
Official title: Opium Tincture Against Chronic Diarrhea - Patients An Investigator Initiated, Randomized Placebo-controlled, Double-blinded, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Diarrhea
Keywords: Diarrhea
Gastrointestinal transit
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-01-19
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bowel movement frequency
timeFrame: From day 1 to 7
Secondary outcomes:
measure: Gastrointestinal transit
timeFrame: Measurement started on day 4 of each study period until expulsion of the capsule]
measure: Stool consistency
timeFrame: From day 1 to 7 in each study period
measure: Pupil diameter
timeFrame: Day 1, 4 and 7 in each study period
measure: General cognition
timeFrame: Day 1, 4 and 7 in each study period
measure: Reaction time
timeFrame: Day 1, 4 and 7 in each study period
measure: Short-term memory
timeFrame: Day 1, 4 and 7 in each study period
measure: Gastrointestinal symptoms
timeFrame: Day 1, 4 and 7 in each study period
measure: Constipation symptoms
timeFrame: Day 1, 4 and 7 in each study period
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University hospital
Study officials:
affiliation: Aalborg University Hospital
name: Asbjørn Mohr Drewes
role: PRINCIPAL_INVESTIGATOR
References: