The change of gut microbiota caused by Vonoprazan and kestose

JRCT ID: jRCTs041190016

Registered date:10/04/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastroduodenal ulcer and after ESD artificial ulcer
• Date of first enrollment: 19/03/2018
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Arm A : Kestose (10g) every day for 8 weeks
Arm B : Maltose(5g) every day for 8week

Outcome(s)

• Primary Outcome: the change of Gut microbiota caused by using Vonoprazan and kestose or placebo for 8 weeks

Secondary Outcome

1. Observation of the change of ulcer healing caused by kestose
2. Changes of short-chain fatty acid (Butyric acid ,Acetic acid, Propionic acid etc.)
3. Changes of pathologic and metabolic marker (T-Cho, LDL-Cho, HDL-Cho, TG, FFA, ferritin, HbA1c, CRP, TP, ALB etc.)
4. Correlation of gut microbiota and bowel habits
5. Changes of body weight and BMI
6. Metabolome, bile acid and protein analysis of metabolite in feces
7. Correlation between expiratory noble gases, gut microbiota and ulcer healing

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients of gastroduodenal ulcer or after ESD artificial ulcer

Exclude criteria

1. Patients continuously using PPI or Vonoprazan
2. Women with pregnancy or possible pregnancy
3. Patients with severe renal failure and heart failure
4. Patient who is considered to be inappropriate for entry into the trial by the investigator
5. Medical doctors decided the patients are inappropriate
6. Patient who has allergy to drugs or foods used in this research

Related Information

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