Genetic, Serological Fecal and Clinical Markers in Siblings of Children With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sample blood and fecal collection
Sponsored by
About this trial
This is an interventional screening trial for Inflammatory Bowel Disease focused on measuring inflammatory bowel disease, siblings
Eligibility Criteria
Inclusion Criteria:
- siblings of children affected with IBD
- children without a family history of IBD
Exclusion Criteria:
- age > 18 years
- age < 6 years
- concomitant autoimmune disorders
Sites / Locations
- Department of Pediatrics, Sapienza University of Rome
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
siblings of patients with IBD
patients without family history of IBD
Arm Description
Blood and fecal samples from 100 siblings of children affected with IBD will be collected at the day of enrolment. Clinical risk factors for IBD will be also recorded in a case report form.
Blood and fecal samples of 100 healthy children without a family history of IBD will be collected at the day of enrolment. Clinical risk factors for IBD will be also recorded in a case report form
Outcomes
Primary Outcome Measures
To evaluate the prevalence of known susceptibility genes for IBD in siblings and twins of patients affected with IBD, compared to controls
To evaluate the prevalence of serological markers of autoimmunity known as risk factors for IBD in siblings and twins of patients affected with IBD, compared to controls
Secondary Outcome Measures
To evaluate the presence and values of fecal markers of colonic inflammation in siblings and twins of patients affected with IBD, compared to controls
Full Information
NCT ID
NCT02181153
First Posted
July 1, 2014
Last Updated
May 10, 2016
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02181153
Brief Title
Genetic, Serological Fecal and Clinical Markers in Siblings of Children With Inflammatory Bowel Disease
Official Title
GENETIC, SEROLOGICAL, FECAL AND CLINICAL MARKERS IN SIBLINGS OF CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although the precise etiology of inflammatory bowel disease (IBD) is still unknown, over the last decade active research allowed to gain more precise insights in the pathophysiology of IBD indicating that the chronic inflammation of the intestinal mucosa is directed against the microbiota of the gut in particularly susceptible individuals. Genetic studies and more recently genome-wide association studies (GWAS) have allowed to identify over 70 susceptibility genes which confer an increased risk of developing IBD. In the last years the attention of researchers has shifted to the identification of the early immunological changes that occur already at a preclinical stage of the disease, trying also at identifying the disease before it shows itself. Recently, the ability of a combination of serological markers in predicting the development of IBD has been demonstrated in adults. However, there are no studies evaluating a cohort of children at high risk for the disease, in whom the first immunological changes underlying the development of IBD could be studied, including a combination of genetic, serological, fecal and clinical markers.
The purpose of this study is to evaluate in a population genetically well-characterized, as siblings and twins of patients affected with IBD, early genetic, serologic, fecal and clinical markers of disease, which may be present even years before developing the disease. The identification of these markers in predisposed individuals could help to implement strategies for prevention or early treatment to modify the natural history of IBD.
Detailed Description
This is a multicenter, prospective, study evaluating the role of serological, genetic, fecal and clinical markers in predicting the development of IBD in a high risk population. The study will be divided in two phases. In the first phase the prevalence of genetic, serologic, fecal, clinical risk factors in 100 siblings of children affected with IBD compared to 100 healthy children with no family history for IBD will be evaluated. The estimated duration of the first phase of the study is 12 months. In a second phase, a long-term follow-up (5 years) will be performed in order to evaluate the accidental cases of IBD in this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
inflammatory bowel disease, siblings
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
siblings of patients with IBD
Arm Type
Other
Arm Description
Blood and fecal samples from 100 siblings of children affected with IBD will be collected at the day of enrolment. Clinical risk factors for IBD will be also recorded in a case report form.
Arm Title
patients without family history of IBD
Arm Type
Other
Arm Description
Blood and fecal samples of 100 healthy children without a family history of IBD will be collected at the day of enrolment. Clinical risk factors for IBD will be also recorded in a case report form
Intervention Type
Other
Intervention Name(s)
sample blood and fecal collection
Intervention Description
Blood and fecal samples will be collected at the day of enrolment
Primary Outcome Measure Information:
Title
To evaluate the prevalence of known susceptibility genes for IBD in siblings and twins of patients affected with IBD, compared to controls
Time Frame
one year
Title
To evaluate the prevalence of serological markers of autoimmunity known as risk factors for IBD in siblings and twins of patients affected with IBD, compared to controls
Time Frame
one year
Secondary Outcome Measure Information:
Title
To evaluate the presence and values of fecal markers of colonic inflammation in siblings and twins of patients affected with IBD, compared to controls
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
siblings of children affected with IBD
children without a family history of IBD
Exclusion Criteria:
age > 18 years
age < 6 years
concomitant autoimmune disorders
Facility Information:
Facility Name
Department of Pediatrics, Sapienza University of Rome
City
Rome
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Genetic, Serological Fecal and Clinical Markers in Siblings of Children With Inflammatory Bowel Disease
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