E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non constipation Irritable Bowel Syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060845 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the effect of Rifaximin 550 mg treatment on the faecal microflora of patients with non-constipation Irritable Bowel Syndrome (non-C IBS). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female or male subjects aged ≥ 18 and < 75; Be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions; Female subject currently either of non-childbearing or with a negative pregnancy test both at screening and baseline; not lactating. For Healthy Volunteers: Clinical laboratory tests at screening showing no clinically significant abnormalities and no relevant concomitant diseases in the opinion of the Investigator. For patients with IBS: Non-constipation IBS defined by Rome II criteria. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E` prevista una analisi preliminare dei campioni provenienti da 5 volontari sani, 10 pazienti con IBS e SIBO e 5 pazienti con IBS. L’ arruolamento proseguira` solo nel caso in cui ci saranno indicazioni di un effetto di rifaximina comune tra pazienti |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |