INF-α Innate Immune Response to Gliadin

Completed

• Conditions: Celiac Disease
• Interventions: Other: Intestinal biopsies

• Registration Number: NCT03221647
• Lead Sponsor: Federico II University

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.

Detailed Description

Intestinal biopsies from CD patients and controls were obtained after EGDS performed during routine analysis. The biopsies were immediately immersed in culture medium (Dulbecco's modified medium, DMEM) in a falcon tube and kept for 16h at 37 C before cultivation. Biopsies were cultivated as described in Barone MV1, Caputo I, Ribecco MT, Maglio M, Marzari R, Sblattero D, Troncone R, Auricchio S, Esposito C. Humoral immune response to tissue transglutaminase is related to epithelial cell proliferation in celiac disease. Gastroenterology. 2007,132(4):1245-53.

Study Timeline

• Study Start: 2013-01-10
• Status Verified: 2017-07
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-17
• Last Update Submitted: 2017-07-17
• Study First Posted: 2017-07-18
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

Exclusion Criteria

other inflammatory intestinal diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Intestinal biopsies	Intestinal biopsies from controls, affected by gastroesophageal reflux,
GFD CD (Gluten Free Diet CD)	Intestinal biopsies	Intestinal biopsies from GCD-CD patients with villous atrophy (Marsh T3a-c) had positive serology (anti-tTg antibodies \>30 U/ml and EMA positive) ).
GCD CD (Gluten Containing Diet CD)	Intestinal biopsies	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).

Primary Outcome Measures

Name	Time	Method
Measurement of Mxa and INF alpha proteins in CD biopsies compared to controls	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Riccardo Troncone; 🇮🇹 Naples, Italy