Medicinal Cannabis for Endometriosis: The Gut Microbiome
- Conditions
- endometriosisReproductive Health and Childbirth - Menstruation and menopauseAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12624000828527
- Lead Sponsor
- Western Sydney University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 42
•Aged 18-50 years.
•Self-reported pelvic pain, severe enough to seek medical attention.
•Diagnosis of endometriosis via laparscopy, MRI or ultrasound imaging by a medical doctor.
•Residing in Sydney.
•Regular menstruation (i.e. 21-35 day cycle)
•Cannabis naïve or have not used illicit cannabis or prescribed cannabinoid-based medications in the previous three months.
•Report no current, or history of, hazardous cannabis use or dependency.
•Agree to keep all study products in a secure location and not to share/distribute cannabis to any other individual.
•If sexually active and pregnancy is a possibility, agree to use appropriate contraception to prevent pregnancy during the study period.
•Able to travel to a Laverty Pathology (or sister site) collection centre for two blood tests
•Safety markers in full blood exam, liver and kidney function (as per blood tests) found within normal ranges.
•Able to complete study questionnaires via invitations sent to email.
•Willing to give informed consent to participate in the study.
•Not residing in Sydney.
•Endometriosis-related surgery in the previous six months
•Not experiencing regular menstruation (i.e. 21-35 day cycle)
•Must not have started, stopped or had a significant dosage of any endometriosis-specific in the last three months including contraceptives, GNRH-a and neuroleptics (changes in ‘as needed’ medications such as analgesics are not reasons for exclusions).
•Must not have any current or past diagnoses that would be considered a risk to participation in the study, including schizophrenia spectrum and other psychotic disorders, bipolar-related disorders, dissociative disorders, personality disorders, cannabis use disorder and obsessive-compulsive related disorders.
•Currently have any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal or neurological disease (determined by the medical monitoring team).
•Has used cannabis in the past 3 months
•Pregnant or planning to become pregnant during the study duration
•Unwilling to use contraception for the duration of the study
•Unable to travel to a Laverty Pathology (or sister site) collection centre for three blood tests
•Full blood exam, liver and kidney function (including urea and electrolytes) safety markers not within normal ranges.
•Current medical condition which in the opinion of the Principal Investigator or medical monitor is a contraindication for medicinal cannabis
•Family history or personal history of drug dependence
•Unwilling to complete study assessments via email.
•Unwilling or unable to provide informed consent to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method