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Alginate combined fecal microbiota transplantation for ulcerative colitis

Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200103
Enrollment
60
Registered
2020-09-01
Start date
2020-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis Ulcerative colitis

Interventions

A-FMT plus algin acid therapy arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM t
Antibiotics FMT algin acid

Sponsors

Ishikawa Dai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 1.Eligible patients are active UC with a total Mayo score 15 of 3 to 10 points and a sum endoscopic mayo score of >=2.And they had exclusion diagnosis of infectious enterocolitis is done. 2.Ages 20 and over 3.Both gender 4.Hospitalized patients or outpatients. 5.Written and oral informed consent with a sufficient understanding. Stool Donors 1.Healthy persons 2.20 year older 3.Both gender 4.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) 5.The donor who the doctor judged that there is no problem in health condition will take the following examinations. 1)Fecal examination: The toxin (C. difficile toxin) and the pathogenic bacteria and parasites (general fecal culture, microscopic parasite egg inspection). 2) Blood test: hepatitis A, hepatitis B, hepatitis C, H IV antibody, HTLV antibody, syphilis (RPR / TP), cytomegalovirus antibody, ameba antibody, tuberculosis. 3) Saliva test: SARS-CoV-2 antigen. 4) Mental symptoms The choice of donor will be made according to the needs of the patient. If a patient wishes a donor known by the investigator, the patient and the donor candidate will be present in front of the doctor confirming their will and sign the consent forms.

Exclusion criteria

Exclusion criteria: Patients 1.Patients using local therapy. 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.Patients with allergic diseases 6.Other cases judged inappropriate by the principal investigator. 7.Patients who were treated with antibiotics within three month 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. 4.Donors who were treated with antibiotics within three month. 5.Donors who have a BMI of 30 or higher.

Design outcomes

Primary

MeasureTime frame
Change of Total Mayo Score at the point of 8 weeks from baseline

Secondary

MeasureTime frame
1.Change of Sum Endoscopic Mayo Score at the point of 8 weeks from baseline 2.Change of metagenome at the point of 8 weeks from baseline

Contacts

Public ContactKei Nomura

Juntendo University Hospital

ke-nomura@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026