Non constipation Irritable Bowel Syndrome MedDRA version: 9.1 Level: LLT Classification code 10060845
Conditions
Interventions
Product Name: Rifaximin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rifaximin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 550-
Sponsors
ALFA WASSERMANN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female or male subjects aged = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis; History of celiac disease, IBD, GI malignancy, GI obstruction, gastroparesis, carcinoid syndrome, pancreatitis, amyloidosis, ileus or cholelithiasis; Diabetes (Type 1 or Type 2); Hyperthyroidism; Lactose intolerance not controlled by lactose free diet; Positive stool culture for pathogenic bacteria, yeast, parasites and viruses; Severe hepatic, renal and cardiac insufficiency; Immunological, haematological or neoplastic disease; Use of any investigational drug within the 3 months prior to screening. For Healthy Volunteers: Subjects with a positive glucose/lactulose breath test; Subject with symptoms related to IBS. For non-C IBS patients: Subject with the symptoms of constipation IBS (Rome II criteria); Subjects with known hypersensitivity to Rifaximin or rifampin or excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of Rifaximin 550 mg treatment on the faecal microflora of patients with non-constipation Irritable Bowel Syndrome (non-C IBS).;Secondary Objective: Assessment of Clinical efficacy: To asses clinical efficacy, the relief of global IBS symptoms, symptom of bloating and abdominal pain/discomfort will be evaluated through a weekly (every 7 days) binary questionnaire. Clinical responders will be defined as those subjects achieving adequate relief of global IBS symptoms, for at least 2 of the first 4 weeks during the evaluation period (i.e., Weeks 2 through 5). Safety evaluation: Vital signs; adverse events, withdrawals due to AEs, safety laboratory parameters.;Primary end point(s): a) To evaluate any difference in faecal microbiota between healthy volunteers and non-C IBS patients at baseline, at the end of the 14 day treatment and after the follow-up period; b) To analyse the effect of rifaximin treatment on the composition of faecal microbiota samples in non-C IBS patients, with particular interest to any qualitative/quantitative change in Firmicutes, Bacteroidetes, Enterobacteriaceae, Bifidobacteria. c) To evaluate whether at the end of the treatment period bacterial strains resistant to rifaximin are selected and whether they are still present in faecal sample at the end of the follow-up period. | — |
Countries
Italy
Outcome results
None listed