An open-label, observational study to investigate efficacy and safety of routinely prescribed oral medicinal cannabis for management of symptoms in patients with irritable bowel syndrome (IBS).

Emyria Limited0 个研究点目标入组 50 人开始时间: 2021年2月1日最近更新: 2023年2月27日

适应症

试验速览

暂无简介。

•1. > 18 years of age at the time of consent
•2. Meets Rome IV criteria for IBS of any subtype [IBS with constipation (IBS-C), IBS with diarrhoea (IBS-D), mixed type IBS (IBS-M) or unsubtyped IBS(IBS-U)].
•3. Abdominal pain should be present for at least 1 day per week for the last 3 months and the origin of the symptoms should be at least 6 months before. The symptoms should be related to at least two of the following:
•a. Related to defecation
•b. Associated with a change in stool frequency
•c. Associated with a change in stool (appearance)
•4. Able and willing to comply with all study procedures
•5. Agrees to NOT drive for duration of study if taking medicinal cannabis products containing THC, in accordance with local laws
•6. Treated with cannabinoid medicines at Emerald Clinics

•1. History of Gastric, small bowel or colonic surgery
•2. Diagnosis of Inflammatory Bowel Disease
•3. Known Coeliac Disease
•4. Diagnosis of cancer (not in remission)
•5. Pregnant or Breastfeeding women
•6. Severe Unstable mental illness (suicidal ideation, psychotic symptoms) based on self-report or depression scores on the DASS greater than or equal to 11 or anxiety scores on the DASS greater than or equal to 12
•7. History of suicide attempt
•8. History of schizophrenia
•9. History of seizures or epilepsy
•10. History of drug or alcohol abuse
•11. Current cannabis use (within 2 weeks) prior to initial assessment visit.
•12. Severe unstable heart disease (unstable angina or ischaemic heart disease, heart failure greater than NYHA Grade 2)

发起方

Emyria Limited