Skip to main content
OpenTrials
Completed

NCT Number: NCT03221647

INF-α Innate Immune Response to Gliadin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riccardo Troncone

Naples, 80131, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

A Gliadin Peptide Regulated the INF-α Immune Response in Celiac Small Intestine and in an En-terocyte Cell Line

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2017
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.