A non-interventional study looking at safety and efficacy of medicinal cannabis prescribed to patients with symptoms of Irritable Bowel Syndrome (IBS).

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000102875
• Lead Sponsor: Emyria Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Study Completion: 2022-09-02
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in overall IBS symptom severity scores in IBS patients treated with medicinal cannabis assessed using the IBS Symptom Severity Scale (IBS-SSS)[baseline, week 2, week 4, week 8, and week 12 (primary timepoint)]

Secondary Outcome Measures

Name	Time	Method
Change in overall sleep in IBS patients treated with medicinal cannabis assessed using the Insomnia Severity Index (ISI). [baseline, week 2, week 4, week 8 and week 12];Change to IBS symptoms in patients with IBS treated with medicinal cannabis assessed using weekly symptom monitoring questionnaire.<br>[baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12];To assess any changes in bowel movements in patients with IBS after commencing medicinal cannabis using Bristol Stool Chart[baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12];Change in overall Quality of Life scores in IBS patients treated with medicinal cannabis assessed using the IBS-Quality of Life (IBS-QOL) scale.[baseline, week 2, week 4, week 8, week 12];Change in overall mood in IBS patients treated with medicinal cannabis assessed using the Depression Anxiety Stress Scales Short Form (DASS-21)[baseline, week 2, week 4, week 8, week 12]