Medicinal Cannabis for Gastrointestinal Symptoms in Endometriosis Clinical Trial
Do you experience gastrointestinal symptoms associated with endometriosis? Do you live in Sydney?
NICM Health Research Institute’s PhD Candidate Ms Toobah Farooqi is leading the GutFloraRx trial.
The research team are seeking participants to be involved in a clinical trial examining the efficacy and safety of two different medicinal cannabis interventions in people with endometriosis and associated gastrointestinal symptoms, such as nausea, vomiting, gastrointestinal discomfort and bloating.
Endometriosis is a chronic inflammatory condition characterizing by the presence of endometrial-like tissue growing outside of the uterus. Many people with endometriosis find it difficult to achieve good gastrointestinal symptom and pain control with conventional treatment strategies. Due to poor pain control, people with endometriosis turn to self-managing symptoms, including using cannabis.
The research team will be testing a CBD only oil compared to a balanced THC:CBD oil. The third group will receive a placebo oil that looks and tastes the same as CBD oil but doesn’t have any active components. All products will be provided free of charge.
Most of the information captured in the trial will be collected online via questionnaires. Participants in the trial will also be required to provide a menstrual blood sample and a faecal sample, and blood tests for safety.
Who can join?
- Aged 18 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.
- Agree to refrain from driving and operating heavy machinery for the duration of the intervention phase (3 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.
- Not pregnant, as indicated by bHCG quantitative measure to be included in baseline blood test.
- Able to complete study questionnaires via invitations sent to email.
- Willing to give informed consent to participate in the study.
What’s involved?
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After an initial assessment and consent, you will:
- Have an appointment with a medical doctor to confirm you are suitable to take medicinal cannabis.
- Have blood taken to assess your liver and kidney function.
- Complete a series of questionnaires online to assess your current level of endometriosis related pain and gastrointestinal symptoms.
- Provide samples of your menstrual blood and faecal sample.
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Participants will then be randomly allocated into one of the treatment groups (CBD only or balanced THC:CBD oil), or a placebo group. Over 3 months, you will be asked to:
- Complete a 10-day dosage phase to determine the best daily dose for your levels of pain and gastrointestinal symptoms.
- Follow the instructions for the investigational products as directed on the label and by research staff.
- Complete questionnaires monthly, which will be sent to you via email.
- Have blood taken at the end of the 3 months to assess your liver and kidney function.
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After two months of completing treatment, participants will be followed-up. This will involve:
- Complete a questionnaire to assess pain and gastrointestinal symptoms.
- Participate in an optional interview to provide feedback on the trial.
What are the benefits of participating?
Participation in the study may help you to manage symptoms of endometriosis. However, please be aware that since there are few similar studies of medicinal cannabis in endometriosis, there may be no direct benefit to you from participating in this study. While the intervention we are testing was found useful in other patient populations, there is no guarantee it will be effective in people with endometriosis. However, this project may benefit the wider endometriosis community. It is likely to provide necessary data to design better treatments for people with endometriosis.
Interested in participating?
For more details about this study, please read the following information before deciding on whether to participate.
In order to express your interest, please complete the online form below. Please be aware that recruitment for this trial is expected to start in March 2025.
If you have further questions, please contact:
Toobah Farooqi
NICM Health Research Institute, Principal Investigator – PhD Candidate
Email: gutflorarx@westernsydney.edu.au
Human Research Ethics Committee Approval: This clinical trial has been approved by the Western Sydney University Human Research Ethics Committee (Approval Number: H16068).
This study is supported by Endometriosis Australia Pty Ltd.
NICM Health Research Institute Principal Investigator: Ms Toobah Farooqi