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Trial registered on ANZCTR


Registration number
ACTRN12621000102875
Ethics application status
Approved
Date submitted
25/11/2020
Date registered
1/02/2021
Date last updated
1/02/2021
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A non-interventional study looking at safety and efficacy of medicinal cannabis prescribed to patients with symptoms of Irritable Bowel Syndrome (IBS).
Scientific title
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).
Secondary ID [1] 302863 0
Emyria Limited (sponsor). Protocol number EMD-010
Universal Trial Number (UTN)
U1111-1261-7354
Trial acronym
CALM-GUT study
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 319861 0
Condition category
Condition code
Oral and Gastrointestinal 317794 317794 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 319153 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325818 0
Change in overall IBS symptom severity scores in IBS patients treated with medicinal cannabis assessed using the IBS Symptom Severity Scale (IBS-SSS)
Timepoint [1] 325818 0
baseline, week 2, week 4, week 8, and week 12 (primary timepoint)
Secondary outcome [1] 389233 0
Change in overall sleep in IBS patients treated with medicinal cannabis assessed using the Insomnia Severity Index (ISI).
Timepoint [1] 389233 0
baseline, week 2, week 4, week 8 and week 12
Secondary outcome [2] 389234 0
Change to IBS symptoms in patients with IBS treated with medicinal cannabis assessed using weekly symptom monitoring questionnaire.
Timepoint [2] 389234 0
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
Secondary outcome [3] 389235 0
To assess any changes in bowel movements in patients with IBS after commencing medicinal cannabis using Bristol Stool Chart
Timepoint [3] 389235 0
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
Secondary outcome [4] 390287 0
Change in overall Quality of Life scores in IBS patients treated with medicinal cannabis assessed using the IBS-Quality of Life (IBS-QOL) scale.
Timepoint [4] 390287 0
baseline, week 2, week 4, week 8, week 12
Secondary outcome [5] 390288 0
Change in overall mood in IBS patients treated with medicinal cannabis assessed using the Depression Anxiety Stress Scales Short Form (DASS-21)
Timepoint [5] 390288 0
baseline, week 2, week 4, week 8, week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 18090 0
Emerald Clinics Ltd - West Leederville - West Leederville
Recruitment postcode(s) [1] 32079 0
6007 - West Leederville

Funding & Sponsors
Funding source category [1] 307281 0
Commercial sector/Industry
Name [1] 307281 0
Emyria Limited
Address [1] 307281 0
43 Oxford Close
West Leederville, WA
6007
Country [1] 307281 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Emyria Limited
Address
43 Oxford Close
West Leederville, WA
6007
Country
Australia
Secondary sponsor category [1] 307918 0
None
Name [1] 307918 0
Nil
Address [1] 307918 0
Nil
Country [1] 307918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307379 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 307379 0
21 (11-23) Burwood Road, Hawthorn, Melbourne, Victoria 3122, AUSTRALIA
Ethics committee country [1] 307379 0
Australia
Date submitted for ethics approval [1] 307379 0
Approval date [1] 307379 0
24/11/2020
Ethics approval number [1] 307379 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107022 0
A/Prof Alistair Vickery
Address 107022 0
Emyria, Ltd.
43 Oxford Close, West Leederville, WA, 6007
Country 107022 0
Australia
Phone 107022 0
+61 412728891
Fax 107022 0
Email 107022 0
alistair.vickery@emeraldclinics.com.au
Contact person for public queries
Name 107023 0
Ms Tracie Ernenwein
Address 107023 0
Emyria, Ltd.
43 Oxford Close, West Leederville, WA, 6007
Country 107023 0
Australia
Phone 107023 0
+61 431544702
Fax 107023 0
Email 107023 0
ternenwein@emyria.com
Contact person for scientific queries
Name 107024 0
Ms Tracie Ernenwein
Address 107024 0
Emyria, Ltd.
43 Oxford Close, West Leederville, WA, 6007
Country 107024 0
Australia
Phone 107024 0
+61 431544702
Fax 107024 0
Email 107024 0
ternenwein@emyria.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results