Immunogenicity of Cholera Vaccine in Children With IBD

NCT ID: NCT03998449

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2020-05-01

Brief Summary

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Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.

Detailed Description

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Conditions

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Cholera Inflammatory Bowel Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cholera vaccination

Two doses of the vaccine against cholera

Group Type EXPERIMENTAL

Vaccination against cholera

Intervention Type BIOLOGICAL

Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.

Interventions

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Vaccination against cholera

Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
* no vaccination against cholera in the past,
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria

* serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) \> 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) \> 40 points for patients with Crohn's disease.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Lukasz Dembinski

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandra Banaszkiewicz, MD, PhD

Role: STUDY_DIRECTOR

Medical University of Warsaw

Locations

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Medical University of Warsaw

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Dembinski2019

Identifier Type: -

Identifier Source: org_study_id

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