Dose Determination and Efficacy Evaluation of the Gastrointestinal ReProgramming (GaRP) Dietary supplement in Irritable Bowel Syndrome patients

Exclusion Criteria65

• Participants who
• Have a body mass index of <18 or >39.9kg/m2.
• 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.
• Have confirmed clinical diagnosis of bile acid diarrhoea and/or are on
• medication for bile acid diarrhoea.
• Have IBS-C as defined by Rome IV Subtype Classification.
• 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.
• Have diagnosed coeliac disease.
• Have had previous abdominal surgery (excluding laparoscopic
• cholecystectomy, appendectomy, hysterectomy, and hernia repair).
• Have radiation proctitis or other known poorly controlled medical conditions
• that could interfere with bowel function.
• Have a malignant disease (other than localised skin cancers) or any
• concomitant end-stage organ failure.
• In the opinion of the investigator, are poor attendees or unlikely for any
• reason to be able to comply with the study requirements.
• 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).
• 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.
• Are taking narcotics (e.g., tramadol, codeine, morphine).
• Have changed their diet routine, e.g. FODMAP, gluten-free, within the past
• month.
• Are taking probiotics.
• 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) .
• Have experienced a cardiovascular event such as congestive heart failure,
• heart attack, stroke, or angina (chest pain) in the past 3 months.
• 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.
• Have planned investigational procedures while participating in this study
• that would interfere with normal food intake or influence abdominal
• symptoms.
• Have known current infection with HIV, or hepatitis A, B, or C.
• Have abnormal laboratory values at screening deemed by the investigator to
• be clinically significant.
• Have a known allergy to pineapple.
• Are pregnant or breast feeding.