Irritable Bowel Syndrome
Conditions
Interventions
Trade Name: Normix
Product Name: Rifaximin
Pharmaceutical Form: Tablet
INN or Proposed INN: Rifaximin
CAS Number: 80621-81-4
Other descriptive name: Normix
Concentration unit: mg milligram(s)
Concentr
Sponsors
The Alimentary Pharmabiotic Centre, University College Cork
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study. 2. Subjects who are pregnant or nursing. 3. Evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but not limited to): Current evidence, or history of (at any time in the past); • inflammatory bowel disease (Crohn's disease or ulcerative colitis) • Lactose intolerance, not on a stable diet • Celiac Disease • laxative abuse (in the clinical judgement of the physician) • gastrointestinal surgery (exceptions include 6 months post-surgery for appendectomy, cholecystectomy, fundoplication without gas bloat, or hiatal hernia repair; 3 months post-surgery for herniorrhaphy without bowel resection) • gastroparesis • GI malignancy • carcinoid syndrome • amyloidosis • chronic pancreatitis • symptomatic gastrointestinal adhesions • toxic megacolon • gastrointestinal perforation • gastrointestinal obstruction and/or stricture. 4. Current evidence of or occurrence within the past 6 months of: • diverticulitis • ileus • symptomatic cholelithiasis • proctitis. 5. Subjects who have taken any medication for the treatment of IBS within 1 month prior to screening except for anti-diarrhoeal medications or laxatives for control of bowel habit which are allowed if at a stable dose for 2 weeks prior to randomisation. 6. Subject is currently taking any prohibited medication, including antibiotics (within 3 month prior to screening) 7. Subjects who are taking NSAIDs including aspirin on a regular basis or within 48 hours of a study day. 8. Systemic or inhaled corticosteroids (Note: topical (e.g. nasal steroid) are allowed). 9. The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. 10. History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. 11. Any other clinically significant laboratory abnormality. 12. Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or in situ uterine cervix cancer that has been resected) within the previous 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identification of a microbial signature associated with Responders versus Non Responders to treatment with Rifaximin. (Response is defined as improved IBS symptoms which will be measured using an IBS symptom severity score and food frequency questionnaires between visits.);Secondary Objective: Identification of microbiome changes that are associated with an alleviation of symptoms.;Primary end point(s): The placebo effect in the IBS dataset is expected to affect 30% of the individuals. ;Timepoint(s) of evaluation of this end point: For all end points at end of Trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 70% of the dataset of 80 IBS subjects is expected to provide a true biological signal;Timepoint(s) of evaluation of this end point: For all endpoints at end of trial. | — |
Countries
Ireland
Contacts
Public ContactDr. Susan Rafferty-McArdle
The Alimentary Pharmabiotic Centre, University College Cork
Outcome results
None listed