Opium Tincture Against Chronic Diarrhea - Patients

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.

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