Genetic, Serological Fecal and Clinical Markers in Siblings of Children With Inflammatory Bowel Disease

NCT02181153 | Completed

• 1 other identifier: 01072014
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

inflammatory bowel disease; siblings

Outcome Measures

Primary Outcomes (2)

• To evaluate the prevalence of known susceptibility genes for IBD in siblings and twins of patients affected with IBD, compared to controls

  one year

• 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

  one year

Secondary Outcomes (1)

• To evaluate the presence and values of fecal markers of colonic inflammation in siblings and twins of patients affected with IBD, compared to controls

  one year

Study Arms (2)

siblings of patients with IBD

OTHER

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.

Other: sample blood and fecal collection

patients without family history of IBD

OTHER

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

Other: sample blood and fecal collection

Interventions

sample blood and fecal collection OTHER

Blood and fecal samples will be collected at the day of enrolment

patients without family history of IBD; siblings of patients with IBD

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• siblings of children affected with IBD
• children without a family history of IBD

You may not qualify if:

• age \> 18 years
• age \< 6 years
• concomitant autoimmune disorders

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Pediatrics, Sapienza University of Rome

Rome, RM, 00161, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 3, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)