Usefulness of kestose in patients with hepatitis B

JRCT ID: jRCTs041230162

Registered date:05/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic hepatitis B
• Date of first enrollment: 05/03/2024
• 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 8 weeks

Outcome(s)

• Primary Outcome: Improvement of hepatitis B virus-related markers (HBs antigen levels)

Secondary Outcome

1.Improvement of hepatitis B virus-related markers (HBV DNA level, HBV core related antigen level)
2.Changes of short-chain fatty acid (Butyric acid, Acetic acid, Propionic acid etc.)
3.Changes of gut microbiome in feces
4.Metabolites in feces (metabolome and protein analysis)
6.Changes of bile acid in blood and feces
7.Changes of cytokine and chemokine
7.Changes of fibrosis markers
8.Changes of body weight and BMI

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients diagnosed as chronic hepatitis B with HBeAg negative

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.
5.Patients with substantial alcohol consumption (20g/day for women or >30g/day for men).
6.Patients with poor glycemic control (HbA1c>9.0%)
7.Patients with other active hepatitis and hepatocellular carcinoma
8.Patients with history of gastrointestinal surgery
9.Patients who take nonabsorbable antibiotic

Related Information

• Primary Sponsor: Takashi Honda