None listed
Conditions
Brief summary
This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and determine the optimal dose of a potential new treatment called GaRP in adults with irritable bowel syndrome. The aim of this study is to determine the efficacy of two different doses of GaRP in IBS patients after 8 weeks of intervention.
Interventions
Arm 1: Dosed with oral GaRP equivalent to 240 mg of bromelain twice a day for 8 weeks
Arm 2: Dosed with oral GaRP equivalent to 480 mg of bromelain twice a day for 8 weeks.
Participants will record the time of dosage in their electronic diaries. All unused product will be returned at the completion of the trial for reconciliation.
Sponsors
Anatara Lifesciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients who: • Have irritable bowel syndrome with a moderate IBS-SSS score of 175-350 as assessed by the IBS-SSS questionnaire. • Have IBS as defined by Rome IV • recurrent abdominal pain on average at least 1 day/week in the last three months associated with two or more of the following: o Related to defecation o Associated with a change in frequency of stool o Associated with a change in form of stool • Have abdominal pain intensity where the weekly average of worst daily (in past 24 hours) abdominal pain score is > 30 on a 0 to 100-point scale at screening • Agree not to make significant changes to their diet or exercise routines during the study. • If a women of child-bearing potential, agrees to use an acceptable method of birth control (true abstinence, birth control pills, injections or contraceptive implants) while on treatment and following completion of 2 menstrual cycles or 2 months after the last dose of study treatment, and if male a barrier method of birth control from randomisation until the Follow- Up visit.
Exclusion criteria
Participants who •1. Have a body mass index of <18 or >39.9kg/m2. 2. Have a significant acute or chronic coexisting illness such as psychiatric*, immunological or cardiovascular (not including controlled hypertension or stable endocrine considerations) that contraindicates, in the investigator’s judgement, entry to the study. a) Participants who have ‘alarm symptoms’ (e.g., unexplained weight loss family history of colon cancer or inflammatory bowel disease or rectal bleeding) may be eligible if organic pathology is excluded by a detailed work-up prior to enrolling the participant. b) * Participants with a psychiatric illness particularly in the category of chronic and non-psychotic, such as anxiety and /or depression, are eligible provided the investigator deems involvement will not to place the participant at risk and that the participant is considered reliable. 3. Have confirmed clinical diagnosis of bile acid diarrhoea and/or are on medication for bile acid diarrhoea. 4. Have IBS-C as defined by Rome IV Subtype Classification. 5. Currently have, or have a history of, inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease), or have a faecal calprotectin level of >50 ug/g at enrolment or C-reactive protein level of >5.0mg/L. 6. Have diagnosed coeliac disease. 7. Have had previous abdominal surgery (excluding laparoscopic cholecystectomy, appendectomy, hysterectomy, and hernia repair). 8. Have radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function. 9. Have a malignant disease (other than localised skin cancers) or any concomitant end-stage organ failure. 10. In the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study requirements. 11. Are currently, or in the past 30 days have been, enrolled in another investigational device or drug study(s), or are currently receiving other investigational agent(s). 12. Have used /weaned from long term systemic corticosteroids or antibiotics within the past month prior to screening or have used short -term systemic corticosteroids or antibiotics within the fourteen days prior to screening. 13. Are taking narcotics (e.g., tramadol, codeine, morphine). 14. Have changed their diet routine, e.g. FODMAP, gluten-free, within the past month. 15. Are taking probiotics. 16. Have chronic drug therapy that interferes with vitamin D metabolism, such as glucocorticoids, or have a chronic disease such as renal failure, liver disease, epilepsy or diabetes mellitus (except for possibly stable type 2 diabetes where the medical management has been unchanged for >6 months on a case-by-case basis in discussion with Principal Investigator, and only on the basis it is deemed not to put the participant at a higher risk of experiencing adverse reaction and/or interfere with the integrity of study outcomes) . 17. Have experienced a cardiovascular event such as congestive heart failure, heart attack, stroke, or angina (chest pain) in the past 3 months. 18. Require concomitant treatment with any prohibited medication. In accordance with Section 8.9, a participant may be permitted to enter the study if they have been on a stable dose for at least 3 months prior to Screening. The Principal Investigator has the discretion to make a definitive call on a case-by-case basis if it is deemed not to put the participant at a higher risk of experiencing clinically significant adverse reaction and/or interfere with the integrity of study outcomes. 19. Have planned investigational procedures while participating in this study that would interfere with normal food intake or influence abdominal symptoms. 20. Have known current infection with HIV, or hepatitis A, B, or C. 21. Have abnormal laboratory values at screening deemed by the investigator to be clinically significant. 22. Have a known allergy to pineapple. 23. Are pregnant or breast feeding.
Outcome results
None listed