Crohn's disease Crohn's disease
Conditions
Interventions
Three antibiotics (amoxicillin, fosfomycin, and metronidazole) will be administered three times daily for seven days.
Amoxicillin hydrate 1,500 mg, orally administered in three divided doses per day.
Crohn's disease
Sponsors
Ishikawa Dai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with Crohn's disease who have active disease and colonic lesions. 2) Patients with a Harvey-Bradshaw Index (HBI) of 7 or higher on the day before eligibility confirmation. 3) Patients who have been diagnosed with Crohn's disease for at least 12 weeks as of the eligibility confirmation date. 4) Patients aged 16 years or older at the time of consent. 5) Outpatient or Inpatient: Only outpatients are eligible. 6) Patients with the capacity to consent and who can provide written informed consent of their own free will. For patients under 18 years of age, written consent must also be obtained from a legal representative.
Exclusion criteria
Exclusion criteria: 1) Patients with a severe allergy to the drugs used in this study. 2) Patients who have undergone the following drug therapies or procedures within the specified periods Antibiotics or antimicrobial agents for Crohn's disease treatment. Within 3 months before eligibility confirmation. Probiotics. Within 1 week before eligibility confirmation. 3) Patients with a history of total colectomy or those scheduled to undergo gastrointestinal surgery during the study period. 4) Patients suspected of having concomitant infectious enteritis based on clinical findings. 5) Patients with tuberculosis. 6) Patients with liver cirrhosis showing signs of portal hypertension. 7) Patients with infections for which no effective antimicrobial agents exist or with deep seated fungal infections. 8) Patients with severe heart disease. 9) Patients with renal impairment. 10) Patients with liver dysfunction. 11) Patients with malignant tumors or those who have not completed a 5year period after cancer treatment. 12) Patients with significant psychiatric symptoms. 13) Patients with a history or complication of drug or alcohol dependence. 14) Pregnant or lactating women, women who may be pregnant, women who wish to conceive from the time of consent to the end of the treatment period, and women who cannot agree to appropriate contraception. 15) Patients who are participating in other clinical research or trials, including follow up studies, at the time of consent. 16) Patients who have received investigational drugs or participated in other clinical trials within 12 weeks before the study required tests and observations. 17) Patients deemed inappropriate for the study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response Rate at Week 8 After FMT Treatment. Clinical response is defined as a decrease of 3 or more points from baseline in the Harvey-Bradshaw Index (HBI). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Clinical Remission Rate at Week 8 After FMT Treatment Defined as a decrease in HBI to below 5. 2)Changes in SES-CD (Simple Endoscopic Score for Crohn's Disease) Evaluated at eligibility confirmation and 8 weeks after FMT treatment initiation. 3)Analysis of Intestinal Immunity Using Mucosal Biopsy Specimens 4)Changes in Gut Microbiota Before and After AFMT 5)Changes in Intestinal Ultrasound Findings Before and After AFMT Assessed at eligibility confirmation, each FMT procedure, and the 8week evaluation point. | — |
Contacts
Public ContactKei Nomura
Juntendo University
Outcome results
None listed