A Pilot Study of Immunomodulatory effects of Inulin-type fructans in a hepatitis B vaccination study in seniors

Completed

• Conditions: vaccination efficacy in healthy seniors; vaccination efficacy; vaccine-specific antibody response

• Registration Number: NL-OMON45385
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Females and males age >55 years
Healthy subjects
Caucasian subjects
Written informed consent
Dutch speaking subjects, i.e. subjects understanding spoken and written Dutch language

Exclusion Criteria

- Presence of acute or chronic diseases (e.g. diabetes mellitus)
- Gastrointestinal disorders (e.g. inflammatory bowel disease, celiac disease)
- Gastrointestinal surgery
- Treatment with antibiotics within 6 months of the start of the study
- Prior vaccination with hepatitis B
- Previous hepatitis B infection
- Immunodeficiency*s
- Use of anti-coagulant drugs
- Vegetarians
- Food intolerance (e.g. gluten or lactose)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter is the hepatitis B specific antibody titer after the<br /><br>second shot of hepatitis B vaccination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameters are peripheral immune cell populations and faecal<br /><br>parameters (microbiota profile, short chain fatty acid levels and IgA levels),<br /><br>to determine the underlying mechanism of the ITF stimulated increase in titer<br /><br>response.</p><br>