INF-α Innate Immune Response to Gliadin

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03221647
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Actual Duration (Months): 53.7
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease	Other: 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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 53 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: A Gliadin Peptide Regulated the INF-α Immune Response in Celiac Small Intestine and in an En-terocyte Cell Line
• Actual Study Start Date: Jan 10, 2013
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Controls Intestinal biopsies from controls, affected by gastroesophageal reflux,	Other: Intestinal biopsies; 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.
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; 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.
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; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riccardo Troncone	Naples		Italy	80131

Sponsors and Collaborators

• Federico II University

Investigators

• Principal Investigator: M.Vittoria Barone, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M. Vittoria Barone, Professor, Federico II University
• ClinicalTrials.gov Identifier: NCT03221647
• Other Study ID Numbers: Innate immunity CD
• First Posted: Jul 18, 2017
• Last Update Posted: Jul 18, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by M. Vittoria Barone, Professor, Federico II University: Celiac Disease; P31-43; Loxorubine; TLR7.
• Additional relevant MeSH terms: Celiac Disease

Study Results

No Results Posted as of Jul 18, 2017