The influence of medication for Crohn's disease on serological response to the influenza vaccination

The influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008043

Enrollment

150

Registered

2012-05-28

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Crohn&#39

Interventions

Influenza Vaccination to Crohn&#39

s disease patients treated with Infliximab Influenza Vaccination to Crohn&#39

s disease patients treated with Elemental diet Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients of Crohn's disease with Infliximab treatments or elemental diet therapy (>1 year) who want to receive Influenza vaccination 2)Patients of upper alimentary tract disorders without crohn's disease and ulcerative colitis who have not been treated with steroid, immunomodulators, anti-TNF reagents, and elemental diet within 16weeks.(Disease Control)

Exclusion criteria

Exclusion criteria: 1)Patients who have been treated with Cyclosporin, Tacrolimus, Methotrexate, Steroids, total parental nutrition,granulocyte/monocyte apheresis therapy within 16 weeks. 2) Patients with severe infection or its complications within 1 year. 3) Patients with severe heart, kidney,liver,blood disease or developmental disorders. 4) Patients with allergic disease (Generalized rash etc.) 5) Patients with history of convulsion. 6) Patients diagnosed as an immune deficiency. 7) Patients with respiratory disease (interstitial pneumonia, bronchial asthma etc.) 8) Patients with allergy against ingredients of Influenza vaccine, hen's egg,or ingredients of hen. 9) Patients with drug or alcohol dependence or its history 10) Patients participated other clinical trial within 16 weeks. 11)Other patients judged as inappropriate bu the physician. 12) Patients received anti-TNF agents within 1 year (Only Elemental diet Groups) 13) Patients do not desire to receive Influenza vaccination.

Design outcomes

Primary

Measure	Time frame
Response Rate of post-vaccination antibody titters against Influenza B/Brisbane.	—

Secondary

Measure	Time frame
1;Response Rate of post-vaccination antibody titters against Influenza A/California,Victoria. 2; CDAI scores at each observation period	—

Countries

Japan

Contacts

Public ContactMasayuki Saruta

The Jikei University School of Medicine Division of Gastroenterology and Hepatology

03-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

The influence of medication for Crohn&#39;s disease on serological response to the influenza vaccination