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Immunomodulatory effects of Inulin-type fructans in a hepatitis B vaccination study.

Immunomodulatory effects of Inulin-type fructans in a hepatitis B vaccination study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21512
Enrollment
36
Registered
2013-04-26
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vaccination response to hepatitis B

Interventions

The study population will consist of healthy Caucasian male volunteers (age 20-30 yrs.), all receiving food grade ITFs
Frutafit®CLR, Frutafit®TEX! or a placebo (fructose). All in combination with the first shot of the annual hepatitis B vaccination received by these volunteers during their bachelor at the Medical Facu
I) Frutafit®CLR+hepatitis B vaccination, II) Frutafit®TEX!+hepatitis B vaccination, III) placebo (fructose)+hepatitis B vaccination. Blood samples (lithium heparin) will be collected at day 0, 7, 14,

Sponsors

University Medical Center Groningen (UMCG) (The Netherlands)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 20-30 yr; 2. Healthy subjects; 3. Male subjects; 4. Written informed consent; 5. Caucasian subjects; 6. Caucasian males; 7. Hepatitis B vaccination; 8. Subjects exposed to patient material; 9. Subjects occupied within the UMCG.

Exclusion criteria

Exclusion criteria: 1. Presence of acute or chronic diseases; 2. Gastrointestinal disorders (e.g. inflammatory bowel disease, celiac disease); 3. Gastrointestinal surgery; 4. Treatment with antibiotics within 6 months of the start of the study; 5. Prior vaccination with hepatitis B; 6. Previous hepatitis B infection; 7. Immunodeficiencies; 8. Use of anti-coagulant drugs.

Design outcomes

Primary

MeasureTime frame
Vaccination titer response to hepatitis B.

Secondary

MeasureTime frame
Changes in immune cell populations, fecal IgA and short chain fatty acids and microbiota composition.

Contacts

Public ContactP. Vos, de

University Medical Center Groningen (UMCG) Pathology and Medical Biology section Immunoendocrinology Hanzeplein 1, EA 11

P.de.Vos@umcg.nl+31 (0)50 3611045

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)