JRCT ID: jRCTs041190010
Registered date:10/04/2019
The usefulness of kestose for ulcerative colitis
Basic Information
Recruitment status | Complete |
---|---|
Health condition(s) or Problem(s) studied | Ulcerative colitis |
Date of first enrollment | 06/04/2018 |
Target sample size | 40 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | arm A Kestose(10g) every day 8 weeksar arm B Maltose(5g) every day 8 weeks |
Outcome(s)
Primary Outcome | Improvement of clinical condition in patients with ulcerative colitis |
---|---|
Secondary Outcome | 1.Changes of short-chain fatty acid (Butyric acid,Acetic acid,Propionic acid etc.) 2.changes of endoscopic score 3.changes of concentration of carprotectin in feces 4.Changes of pathologic and metabolic marker (T.Cho, LDL-Cho, HDL-Cho, TG, FFA, ferritin,HbA1c,CRP,TP,ALB etc.) 5.Correlation of gut microbiota and therapeutic effect 6.Changes of body weight and BMI 7.Metabolome and protein analysis of metabolite in feces 8.Changes of bile acid 9.Correlation between expiratory noble gases, gut microbiota and ulcerative colitis 10.Correlation between usefulness of kestose and disease prognosis in the patients with ulcerative colitis |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
---|---|
Age maximum | <= 80age old |
Gender | Both |
Include criteria | Patients with active ulcerative colitis (Lichtiger CAI>3) |
Exclude criteria | 1.Women with pregnancy or possible pregnancy 2.Patients with severe renal failure and heart failure 3.Patient who is considered to be inappropriate for entry into the trial by the investigator 4.Medical doctors decided the patients are inappropriate. |
Related Information
Primary Sponsor | Honda Takashi |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | B Food Science Co., Ltd |
Secondary ID(s) |
Contact
Public contact | |
Name | Syuuji Ikegami |
Address | 65 Tsurumai-cho Syowa-ku Nagoya, Japan Aichi Japan 466-8560 |
Telephone | +81-52-744-2169 |
s.ikegami@med.nagoya-u.ac.jp | |
Affiliation | Nagoya university |
Scientific contact | |
Name | Takashi Honda |
Address | 65 Tsurumai-cho Syowa-ku Nagoya, Japan Aichi Japan 466-8560 |
Telephone | +81-52-741-2111 |
honda@med.nagoya-u.ac.jp | |
Affiliation | Nagoya university |