Opium Tincture Against Chronic Diarrhea - Patients

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asbjørn Mohr Drewes
• Collaborator: Aarhus University Hospital
• Treatments: Opium

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