Subjects with moderate Crohn'
Conditions
Interventions
Daikenchuto or placebo (1:1) will be administered orally as 5g three times daily for 8 consecutive weeks. Up to a 14 day screening period (Visit 1) will precede the treatment period (Visits 2 through
Sponsors
Keio University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Must have Crohn's disease for at least 3 months before the study, confirmed by radiographic, endoscopic, or histological methods. 2) Must have the ability to orally ingest study medication. 3) Be male or female between 18 to 75 years of age. 4) Be diagnosed with Crohn's disease and have a CDAI score of 220-300 points at the time of screening for moderate Crohn's disease. 5) Has no clinically significant deviations in hematologic, hepatic, or renal function parameters as determined by standard laboratory tests, such as liver disorders, kidney disorders, heart failure, blood disorders, or metabolic disorders. 6) If stable doses of the follow medications are taken for at least 4 weeks before screening, the dose must continue through the end of the study: azathioprine, 6-mercaptopurine, methotrexate, 5-aminosalicylates, sulfasalazine, or Crohn's disease -related antibiotics including ciprofloxacin or metronidazole. Antibiotics for non-Crohn's disease related infections are allowed as long as they are not antibiotics commonly used to treat Crohn's disease. 7) Any probiotics must be taken at a stable dose for 2 weeks prior to randomization and throughout the course of the study. 8) Patients who were explained the study schedule and agreed to participate by their own will, accompanied by written informed consent. When patients are under the age of 20, written informed consent must be obtained by their legal guardians as well as by themselves.
Exclusion criteria
Exclusion criteria: 1) History of any bowel condition that may interfere with evaluation of TJ-100, including any bowel resection within 6 months of screening, an extensive bowel resection (>100 cm), short-bowel syndrome, mechanical or uncorrected anatomical bowel obstruction, an ostomy, symptomatic obstructive strictures, a positive stool culture including Clostridium difficile stool assay, or enema therapy within 2-weeks of screening. 2) Female subjects who are pregnant, breastfeeding or planning to become pregnant. 3) History of clinically significant alcohol or drug abuse within a year of screening. 4) Medical history of malignancy within the past 5 years (except for basal or squamous cell carcinoma if the subject is considered recovered). 5) Current diagnosis of ulcerative colitis, scleroderma, Hirschsprung's disease, Chagas disease, multiple sclerosis, Parkinson's disease, stroke, paraplegia, quadriplegia, insulin -dependent diabetes mellitus, untreated hypothyroidism, or any other systemic or psychiatric disorder which may, in the opinion of the investigator, interfere with the evaluation. 6) Current use of any of the following medications: agents with anticholinergic effect; antidepressants are permissible if the subject's symptoms are stable and the doses are not changed during the course of the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects showing a clinical response, as measured by a 100 point reduction in CDAI total score from baseline (Visit 2) to Visit 4. | — |
Countries
Japan
Contacts
Public ContactKatsuyoshi Matsuoka
Keio University, School of Medicine Division of Gastroenterology & Hepatology
Outcome results
None listed