A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease
- Conditions
- Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
- Registration Number
- JPRN-jRCTs031180415
- Lead Sponsor
- Ishikawa Dai
- Brief Summary
Regarding the main evaluation, both efficacy and remission rates were higher than those in previous study data (efficacy rate 56.3%, remission rate 34.5%, Koki Okahara, et al. Clin Med. 2020) in the evaluation of treatment efficacy using CAI, but we believe this was due to the small number of cases. Although no association between blood collection data and efficacy was observed, sap cells and phenomena were associated with therapeutic efficacy in pathological examination, suggesting that there is an associa
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 7
Patients
1. UC patients or CD patients (mild to severe) whose exclusion diagnosis of infectious enterocolitis is done.
2. Hospitalized patients or outpatients.
3. Written and oral informed consent with a sufficient understanding. For minors, in addition to informed assent, informed consent from a custodial person or a guardian.
Stool Donors
1. Healthy persons.
2. The choice of donor will be made according to the needs of the patient.
1) If we use relatives of patients as donor, the patient and their donor candidate will be present in front of the doctor confirming their will and sign the consent forms.
2) If we use non-relative as donor, one of those who have participated in this study or previous clinical studies of our department (Juntendo University Hospital Ethics Committee receipt number: 14-017 or 15-059) or a healthy person whom the investigator judges to have no health problem and who meets other donor selection criteria can be recommended to the patient as a donor.
3. A doctor interviews the donor candidate about the health condition, the past medical history, the life history, and the candidate answers correctly (those who refuse to answer are not allowed to participate).
4. Those who the doctor judged that there is no problem in health condition will take the following examinations.
1) Fecal examination: C.difficile toxin, Microscopy and culture, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Yersinia, and Campylobacter, Ova, cysts, and parasites, fecal occult blood test
2) Blood test: Hepatitis A virus IgM, Hepatitis B virus surface antigen, hepatitis B virus surface antibody, hepatitis B virus core antibody, Hepatitis C virus antibody, HIV type 1 and 2, Human T-cell lymphotropic virus 1, Syphilis (RPR/TP), Cytomegalovirus antigen (C7-HRP), Entamoeba histolytica antibody, Tuberculosis (T-SPOT), Epstein-Barr virus IgM (VCA-IgM), Complete blood count, Electrolytes, urea, and creatinine. Erythrocyte sedimentation rate, C-reactive protein, Liver function tests, Albumin, Hepatitis E virus.
Patients
1. Those from whom the informed consent is not obtained.
2. All cases with liver disease, kidney disease, heart disease and other serious complications, judged inappropriate by the attending doctor.
3. Cases with complications of other autoimmune diseases.
4. Nursing women, pregnant women and all cases with the possibility of pregnancy.
5. Other cases judged inappropriate by the principal investigator.
Stool Donors
1. Those from whom the informed consent is not obtained.
2. Cases suspected of the infectious diseases in inquiries, blood test and fecal examination screening or having a past disease to be excluded.
Excluded disease:
Inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, severe constipation, colonic polyps, colon cancer, autoimmune diseases, atopic dermatitis, severe obesity, chronic fatigue syndrome.
3. Other cases judged inappropriate by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Efficacy (clinical activity index, endoscopic score), Factors of efficacy (microbiota composition, blood data, pathological tissue analysis)
- Secondary Outcome Measures
Name Time Method