臨床研究等提出・公開システム

Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease

FMT for Crohn's disease (FEMTRAC) study

8

Male 7(Average 30.85, Median 41) Female 1(Age 19)

We established a fecal bank, enrolled in Japan Registry of Clinical Trials. We have entered 8 cases by 30 September 2020.

After a colonoscopy,Crohn's disease worsened. In another hospital,surgical resection was performed. Fecal microbiota transplantation (FMT) had not been performed yet.

By January 2022,7 cases(male/female:7/0,1 small bowel type,5 small bowel colon type,1 large bowel type)underwent FMT. CDAI improvement at 8 weeks was 3/5(60%) in the FMT group and 1/2(50%) in the control group;decrease of 70 scores or more in both groups was 0. Remission(<150) at 8 weeks was achieved in 1/5(20%) in the FMT group and 0/2(0%) in the control group. Serum CRP and Alb were improved in 4/5(80%) in the FMT group and 1/2(50%) in the control group;IBDQ was improved in 3/5(60%) in the FMT group and 1/2(50%) in the control group. End expiratory hydrogen analysis 4/7(57%),SIBO was positive in 3/5 in the FMT group and improved in 1case after FMT;positive in 1/2 in the control group unchanged. SES-CD was improved in 2/4(50%) in the FMT group and in 0/2(0%) in the control group. Regarding alpha diversity of fecal microbiota,Chao1 index was improved in 5/7(71%) in the FMT group and 0/2(0%) in the contol group. Shannon index was improved in 3/7(43%) in the FMT group and 1/2(50%) in the control group. Solenson index was elevated in 5/7(71%) but not changed in 2/7(29%) after FMT. In the 3patients whose clinical activity was improved after FMT,LEfSE analysis revealed increase in butyrate-producing bacteria such as Dorea and Coprococcus.

FMT reduced CDAI in 60% of patients with Crohn's disease,but the degree of improvement of activity including CDAI and other blood markers was mild. Approximately 70% of patients who underwent FMT had increased alpha diversity in their fecal microbiota. Their gut bacteria resembled the flora of donors. But similarities did not necessarily associate with improved clinical activity. In FMT-effective cases,significant increases in butyrate-producing bacteria were observed.

April. 01, 2025

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs041190022

Ohmiya Naoki

Fujita Health University Hospital

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi

nohmiya@fujita-hu.ac.jp

Ohmiya Naoki

Fujita Health University Hospital

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi

+81-562-93-9240

nohmiya@fujita-hu.ac.jp

Complete

April. 22, 2019

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

Patients with active Crohn's disease (CDAI 150 or more)

1.past history of allergy to drugs used in this study
2.possible of documented pregnant women
3.patients with fistula, penetration, and perforation except anal fistula

Both

Crohn's disease

fecal microbiota transplantation

D003424

D000069467

Improvement of CDAI score

1. IBDQ
2. modified SESCD
3. hydrogen and methane level in glucose breath test
4. urine lactulose mannnitol ratio
5. change in fecal microbiome and metabolome

+81-562-93-2865

April. 08, 2019

none