Stage 2 IBS Clinical Trial

This study is seeking to evaluate the safety and efficacy of a complementary medicine in people with Irritable Bowel Syndrome (IBS).

This potential complementary medicine is called GaRP which stands for Gastrointestinal Reprogramming (GaRP) and the study is looking at the safety and efficacy of the medicine.

This study will help us learn more about a new complementary medicine and how it affects your abdominal pain and diarrhoea. The medicine is a formulation consisting of five natural ingredients: bromelain, peppermint oil, L-threonine, sodium butyrate and vitamin D. Each of these components was selected to assist patients with chronic bowel conditions and associated symptoms through collectively:

• Restoring the homeostasis of the dysfunctional microbiome
• Reducing gastrointestinal inflammation
• Promoting mucosal healing
• Restoring intestinal epithelial barrier integrity

Why should I take part?

• You may receive an active drug that could help control your IBS symptoms
• You will be contributing to important research that may help people with IBS or abdominal pain in the future
• You will speak to a nurse regularly throughout the study to share your experiences and symptoms
• You will receive $100 payment at each study visit to cover any expenses associated with attending the study visit

What does the study involve?

Eligible participants will be randomly assigned (like tossing a coin) to receive one of two treatment groups:

• Group 1 - twice daily oral administration of GaRP for 8 weeks
• Group 2 - twice daily oral administration of Placebo for 8 weeks

This study is double blinded, which means that neither you or us will know whether your treatment is active or placebo.

If you decide to take part in the study, you will be required to participate for approximately 12 weeks. This includes 1-2 weeks of screening, 8 weeks of treatment and 2 weeks of follow-up. This includes weekly questionnaires, fortnightly calls with a study nurse and three in-person visits. You will be reimbursed for your time and travel to appointments.

This study is funded by Anatara Lifesciences

This study is HREC approved by Bellberry Limited