INF-α Innate Immune Response to Gliadin

NCT03221647 | Completed DMC

• 1 other identifier: Innate immunity CD
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Background \& Aims The enteropathy in Celiac Disease (CD) is due the adaptive and to the innate immune response to gliadin peptides. Gliadin peptide P31-43 activates innate immune response and interferes with vesicular trafficking. Type 1 interferons (INFs) and viral infections play a role in CD pathogenesis. In this paper investigators investigated the role of P31-43 in the activation of the INF-α pathway. Methods Small intestinal biopsies of CD patients both with active disease on gluten containing diet (GCD) and in remission phase of the disease on a gluten free diet (GFD) and controls were analyzed before and after culture with P31-43. The levels of toll like receptor 7 (TLR7), myeloid differentiation primary response 88 (MyD88), myxovirus resistance protein 1 (MxA) and nuclear factor-κB (NF-κB) proteins and INF-α mRNA was analyzed in intestinal biopsies.

Conditions

Celiac Disease

Keywords

Celiac Disease; P31-43; Loxorubine; TLR7.

Outcome Measures

Primary Outcomes (1)

• Measurement of Mxa and INF alpha proteins in CD biopsies compared to controls

  Intestinal biopsies from CD patients and controls were used to study protein levels of MxA and INF-alpha by western blot. MxA protein levels were compared to tubulin and ERK as loading control. Student t test was used to analyse the data.

  through study completion, an average of 1 year

Study Arms (3)

Controls

Intestinal biopsies from controls, affected by gastroesophageal reflux,

Other: Intestinal biopsies

GCD CD (Gluten Containing Diet CD)

Intestinal biopsies from GFD patients had with negative serology (anti-tTg antibodies between 0 and 1.5 U/ml and EMA negative) and normal biopsy (Marsh T0-1).

Other: Intestinal biopsies

GFD CD (Gluten Free Diet CD)

Intestinal biopsies from GCD-CD patients with villous atrophy (Marsh T3a-c) had positive serology (anti-tTg antibodies \>30 U/ml and EMA positive) ).

Other: Intestinal biopsies

Interventions

Intestinal biopsies OTHER

Intestinal biopsies obtained from Patients and Controls by EGDS. The patients and controls had the intestinal biopsies as a diagnostic step or routine check independently from the present study. For this study 3 additional biopsies samples were done in patients and controls that signed the informed consent.

Controls; GCD CD (Gluten Containing Diet CD); GFD CD (Gluten Free Diet CD)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

For organ culture studies, biopsy fragments from duodenum were obtained from CD patients with villous atrophy on GCD, controls, affected by gastroesophageal reflux, and CD patients on GFD. Age range for all subjects was 2-17 years.

You may qualify if:

• biopsy fragments from duodenum were obtained from CD patients with villous atrophy on GCD, controls, affected by gastroesophageal reflux, and CD patients on GFD.

You may not qualify if:

• other inflammatory intestinal diseases

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Riccardo Troncone

Naples, 80131, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Intestinal biopsies from CD patients and controls obtained during routine analysis. Informed consensus statement obtained from all subjects or their tutors.

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• M.Vittoria Barone

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 18, 2017
• Study Start: January 10, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: the statistical analysis will be published
• Access Criteria: Publication on international journal

Locations

IT (1)