The usefulness of kestose for ulcerative colitis

JRCT ID: jRCTs041190010

Registered date:10/04/2019

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
• 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
• Source(s) of Monetary Support: B Food Science Co., Ltd