Dose Determination and Efficacy Evaluation of the Gastrointestinal ReProgramming (GaRP) Dietary supplement in Irritable Bowel Syndrome patients
- Conditions
- Irritable Bowel SyndromeOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12620001209987
- Lead Sponsor
- Anatara Lifesciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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:
oRelated to defecation
oAssociated with a change in frequency of stool
oAssociated 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.
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 cl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0<br><br>The individual components are recognised as generally safe, however it is possible that adverse events could occur from the mixture of the components together. Some side effects of the components of this supplement in the literature include : flatulence, nausea/vomiting, diarrhoea, epigastric pain/heartburn, allergic rash, dizziness, obstipation (severe constipation), meteorism (swollen abdomen), headache, throat irritation/ oro-pharyngeal pain, dyspepsia, dry mouth, loss of appetite, increased thirst and increased urination[ Baseline to EOT 8 weeks];IBS-SSS scale scores as a continuous variable at Days 7, 14, 28, 42 and 56[ baseline and 7, 14, 28, 42 and 56 days post baseline]
- Secondary Outcome Measures
Name Time Method