NCT03998449

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

June 24, 2019

Last Update Submit

May 19, 2020

Conditions

CholeraInflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Achieving seroprotective antibody concentration

    Serum antibody concentration indicating protection against cholera.

    4-6 weeks after the second dose

Secondary Outcomes (2)

  • Adverse effects

    3 days after each dose

  • Inflammatory bowel disease exacerbation occurrence.

    4-6 weeks after the second dose

Study Arms (1)

Cholera vaccination

EXPERIMENTAL

Two doses of the vaccine against cholera

Biological: Vaccination against cholera

Interventions

Vaccination against choleraBIOLOGICAL

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

Cholera vaccination

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, 02-091, Poland

Location

MeSH Terms

Conditions

CholeraInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Aleksandra Banaszkiewicz, MD, PhD

    Medical University of Warsaw

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

August 30, 2017

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)