Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial
- Conditions
- Chronic Intestinal Pseudo-obstruction
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 12
- Outpatients aged >=20 and < 75 years old on the day of informed consent (IC)
- Patients with CIPO (designated intractable disease 99) at enrollment, meeting all the criteria specified in (1) to (7) of the CIPO Diagnostic Criteria issued in 2014 by the MHLW Research Group, or patients with CIPO, secondary to systemic scleroderma, meeting all the same criteria specified in (1) to (6)
- Patients with GSS, a 4 Likert scale of abdominal bloating symptom level from 0 to 3, of 2 or 3 at the time of IC acquisition and enrollment.
- Patients with malignant diseases (excluding those with stable symptoms and not requiring aggressive treatments such as chemotherapy and/or surgical therapy)
- Patients with psychiatric diseases (excluding those with stable symptoms, and judged appropriate for efficacy assessment without any concern by the investigator or coinvestigators)
- Patients with severe diabetes within 5 weeks before enrollment (HbA1c > 10%)
- Patients with gastrostomy (including percutaneous sendoscopic gastro-jejunostomy, PEG-J), enterostomy, or colostomy for decompression
- Patients who underwent intestinal decompression therapy not associated with surgical procedures (trans-nasal ileus tube) within 4weeks before enrollment
- Patients who used antimicrobials, antiparasitics or antifungals (excluding topical use) within 4 weeks before enrollment
- Patients who have changed the doses of the following concomitant medications within 4 weeks before enrollment: mosapride, daikenchuto, metoclopramide, acotiamide
- Patients with severe liver dysfunction within 5 weeks before enrollment (who meet one or more of the following criteria: AST >= 5 times the upper limit of the common reference value specified in the Japanese Committee for Clinical Laboratory Standards (JCCLS), ALT>= 5 times the upper limit of the common reference value specified in JCCLS, total bilirubin >= 3 times the upper limit of the common reference value specified in JCCLS, decompensated liver cirrhosis, or jaundice)
- Patients who are pregnant, breastfeeding, possibly pregnant, or with desire to get pregnant
- Patients with a previous history of hypersensitivity to any investigational product ingredients
- Patients with active tuberculosis
- Patients who participated in other clinical trial (including a trial with an investigational product) and received an intervention with a test drug within 12 weeks before this enrollment
- Patients judged inappropriate for enrollment in the trial by the investigator or coinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS) at the end of administration (4 weeks) Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
Improvement ratio (%) in Gastrointestinal (GI) symptoms score Improvement ratio (%) in Gastrointestinal (GI) symptoms score
- Secondary Outcome Measures
Name Time Method Changes of each score in Global Symptomatic Score other than abdominal bloating score (additional symptoms) Changes of each score in Global Symptomatic Score other than abdominal bloating score of the following symptoms are assessed;a. diarrhea, b. epigastric pain/discomfort, c. abdominal distention, d. pain in the lower quadrant/discomfort, e. tenderness, f. nausea, g. vomiting).
Changes of the "good" ratio (%) in gastrointestinal symptoms score Changes of the "good" ratio (%) in gastrointestinal symptoms score
Changes of the improvement ratio (%) in General health condition (symptoms) score Changes of the improvement ratio (%) in General health condition (symptoms) score
Changes of the improvement ratio (%) in gastrointestinal symptoms score Changes of the improvement ratio (%) in gastrointestinal symptoms score
Changes of the improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS) Changes of the improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
Changes of abdominal bloating score in Global Symptomatic Score (GSS) Changes of abdominal bloating score in Global Symptomatic Score (GSS)
Changes of each score in Global Symptomatic Score other than abdominal bloating score Changes of each score in Global Symptomatic Score other than abdominal bloating score of the following symptoms are assessed; (a. diarrhea, b. epigastric pain/ discomfort, c. pain in the lower quadrant/discomfort, d. tenderness, e. nausea, f. vomiting).
Changes of the "good" ratio (%) in General health condition (symptoms) score Changes of the "good" ratio (%) in General health condition (symptoms) score
Changes of the improvement ratio (%) in patient satisfaction score Changes of the improvement ratio (%) in patient satisfaction score
Changes of Short Form (SF)-8 health survey score Changes of Short Form (SF)-8 health survey score
Changes of small intestinal volume measured by abdominal CT scan Changes of small intestinal volume measured by abdominal CT scan
Changes of Serum endotoxin activity Changes of Serum endotoxin activity
Fecal test (intestinal flora) Fecal test (intestinal flora)
Incidence of adverse events Incidence of adverse events
Changes from baseline of nutritional assessment parameters Changes from baseline of nutritional assessment parameters
Changes from baseline of laboratory test parameters Changes from baseline of laboratory test parameters
Small intestinal bacterial overgrowth (SIBO) in a glucose-hydrogen breath test Small intestinal bacterial overgrowth (SIBO) in a glucose-hydrogen breath test