Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome
Ključne besede
Povzetek
Opis
Recent evidence suggests that a shift in the host-gut microbial relationship as seen in small intestinal bacterial overgrowth (SIBO) may contribute to the pathogenesis of IBS.Overgrowth of microbiota in the small intestine can cause excessive gas production and malabsorption with a variety of nonspecific symptoms, such as diarrhea, gas bloating, abdominal pain and constipation.Glucose (GBT) and lactulose (LBT) breath test have been proposed as simple, inexpensive and non-invasive diagnostic tools for detecting SIBO with respect to the gold standard (the culture of intestinal aspirates). Many antibiotics have been proposed in the last years for SIBO eradication.Rifaximin is a rifamycin derivative with antibacterial activity caused by inhibition of bacterial synthesis of RNA and which is effective against both gram-positive and -negative bacteria, including aerobes and anaerobes.As <0.1% of its oral dose is absorbed, rifaximin administration is associated to a very low side-effect incidence. However,there are still no effective and reliable treatment for IBS,so we intend to explore the prevalence of SIBO in IBS-D patients and evaluate the efficacy of rifaximin for IBS-D in Chinese population.
Datumi
| Nazadnje preverjeno: | 05/31/2015 |
| Prvič predloženo: | 09/28/2015 |
| Predviden vpis oddan: | 09/29/2015 |
| Prvič objavljeno: | 09/30/2015 |
| Zadnja posodobitev oddana: | 09/29/2015 |
| Zadnja posodobitev objavljena: | 09/30/2015 |
| Dejanski datum začetka študija: | 09/30/2015 |
| Predvideni datum primarnega zaključka: | 09/30/2017 |
| Predvideni datum zaključka študije: | 11/30/2017 |
Stanje ali bolezen
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Rifaximin group Patients are treated with rifaximin (Alfa Wassermann Pharmaceutical Co., Ltd. Italy) for 14 days at a daily dosage of 1200 mg (400 mg, three times daily) |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Metoda vzorčenja | Non-Probability Sample |
| Sprejema zdrave prostovoljce | Da |
| Merila | Inclusion Criteria: 1. aged 18-65 yr; 2. IBS-D fulfiling the ROME III criteria; 3. had undergone a colonoscopic examination within the previous 2 years; 4. had received a diagnosis of and had current symptoms of IBS, in particular, symptoms of abdominal pain and discomfort; and did not have adequate relief of global IBS symptoms and of IBS-related bloating at both the time of screening and the time of randomization. Exclusion Criteria: 1. age <18 years; 2. use of antimicrobial agents within the previous 3 months; 3. known hypersensitivity to agents belonging to rifamycin and/or tetracycline families; 4. pregnancy or breast-feeding; 5. evidence of major concomitant diseases (including tumours and hepatic and ⁄ or renal insufficiency); 6. not on antibiotic treatment or probiotics for at least 4 weeks prior to undergoing the LHBT; 7. fibre supplements or laxatives 1-week prior to the LHBT test date 8. presence of endoscopic or histological alterations, which might be indicative of other disorders (e.g. celiac disease, inflammatory bowel disease, diverticulosis or diverticulitis) and contribute to IBS symptom generation, 9. evidence of major concomitant diseases (including tumours and hepatic and/or renal insufficiency) 10. unstable thyroid disease 11. bowel obstruction 12. known lactose intolerance 13. any evidence of advanced organic or psychiatric disease that may impact on the patient's compliance or adherence to the study protocol. 14. use of medications known to cause constipation (eg, narcotics, antidiarrheals, alosetron) 15. history of abdominal surgery involving the gastrointestinal tract such as appendicectomy, cholecystectomy 16. Inability to sign or rejection to informed consent |
Izid
Primarni izidni ukrepi
1. the proportion of patients who had adequate relief of global IBS symptoms [12 weeks]
Ukrepi sekundarnega rezultata
1. the proportion of patients who with positive lactulose hydrogen breath test change to be negative [2 weeks]
2. the composition of patients's fecal microbiota [2 weeks]
