A double-blind, randomised, placebo-controlled clinical trial to investigate the efficacy and safety of Cannabidiol (CBD) oral oil versus placebo, for the management of abdominal pain in patients with irritable bowel syndrome (IBS)

SC3PO: A double-blind, randomised, placebo-controlled clinical trial to investigate the efficacy and safety of Cannabidiol (CBD) oral oil versus placebo, for the management of abdominal pain in patients with irritable bowel syndrome (IBS)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001179729

Acronym

GENESIS STUDY

Enrollment

195

Registered

2022-09-01

Start date

2023-06-16

Completion date

2024-10-15

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a double-blind, randomised, placebo-controlled clinical trial seeking to investigate the efficacy and safety of Cannabidiol (CBD) oral oil versus placebo, for the management of abdominal pain in patients with irritable bowel syndrome (IBS). Given CBD’s noted anxiolytic, antidepressant, immunomodulatory, and anti-inflammatory activity, we believe that CBD will be a safe and potentially effective candidate for use in adults with IBS. Many gaps still exist in our knowledge on the efficacy and safety of cannabidiol in the clinical setting for the management of symptoms of IBS. However, with suboptimal therapeutic effects, and associated side-effects, of pharmaceutical drugs such as antidepressants, anticholinergics and opioids, this has led to this study being developed to explore CBD as a potential therapy for IBS. As such,this study will determine whether CBD may alleviate the broad list of symptoms which may present in IBS patients.

Interventions

Participants suffering abdominal pain from IBS will be administered cannabis CBD oil or a matching placebo oil, in an oral liquid. The dose administered will be 50mg twice daily for a total of 100mg/day of CBD. This duration will last four weeks. The strategy used to monitor adherence to dosing will be the deployment of a daily dosing diary. Also, the bottle is 30ml, and with 1ml (100mg/CBD) to be taken daily, each participant cannot exceed the recommended dose.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

- 18 years of age and over to a maximum of 70 years of age at the time of consent; - 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)]. - The 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: o Related to defaecation; o Associated with a change in stool frequency; o Associated with a change in stool (appearance); - Able and willing to comply with all study procedures.

Exclusion criteria

- History of gastric, small bowel or colonic surgery; - Diagnosis of Inflammatory Bowel Disease (IBD) such as Ulcerative Colitis or Crohn’s Disease; - Known Coeliac Disease; - Diagnosis of Cancer (not in remission); - Pregnant, Breastfeeding, or trying to conceive (both women and men); - History of suicide attempt in the last 5 years; - History of schizophrenia; - History of seizures or epilepsy; - Recent history of drug or alcohol dependency (<12 months) ; - Current cannabis use (NYHA Grade 2); - Allergies to MCT oil or Cannabidiol; - History of liver or renal disease.

Outcome results