None listed
Conditions
Brief summary
CALM-GUT study is an observational study that aims to evaluate cannabinoid based medicines as a potential therapy for reducing symptoms of irritable bowel syndrome (IBS). Patients over 18 years of age who attend Emerald Clinics for treatment of IBS symptoms with cannabinoid based medicines will be offered participation in the study. Patients are observed for 12 weeks, using a combination of validated questionnaires, self-reported symptoms, and regular follow up with a specialist GP or gastroenterologist. Baseline symptoms and responses to questionnaires will be compared to results after 12 weeks to determine if the treatment is safe and effective in this patient cohort.
Interventions
Patients referred to Emerald Clinics for the management of IBS symptoms and who are determined to be eligible for medicinal cannabis through the SAS or AP schemes will be offered participation in this observational study. Participants are eligible for the study if they are 18 years or older, meet the Rome IV criteria for IBS of any subtype including IBS with constipation (IBS-C), IBS with diarrhoea (IBS-D), mixed type IBS (IBS-M) or unsubtyped IBS(IBS-U), have had symptoms for more than 6 months, and consent to participate in the study. This is an open-label observational, prospective, longitudinal cohort study of eligible patients treated with cannabinoid medicines at Emerald Clinics to determine if IBS symptoms improve with treatment and if treatment is well tolerated with minimal side effects. Since this is an observational study, product type and dosage is not defined and will be determined by the treating doctor as approved through the TGA SAS and AP scheme. Treatment dosing is in accordance with Emerald clinical experience of dosing titration of cannabinoid medicine until a optimal therapeutic effect is obtained, well-tolerated with minimal side effects. After dosing titration, the doctor will make a recommendation on the optimal dose and the patients will continue on the same product(s) for the 12 week treatment period as tolerated. Dosage and product may continue to be adjusted by the prescribing doctor to optimise effect and minimise adverse events, under the conditions of approval through the TGA SAS and AP. Assessments in this observational study will be conducted weekly using Web Application, with doctor review conducted at baseline, week 2, week 4, week 8 and week 12.
Sponsors
Eligibility
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)