Celiac Disease Clinical Trial
Official title:
Lymphocytic Enteritis and Suspected Coeliac Disease: Double-blind Gluten vs Placebo Rechallenge
Patients with lymphocytic enteritis (LE), HLA-DQ2/8+, negative celiac serology and clinical
and histological response to a gluten-free diet (GFD) do not fulfil the diagnostic criteria
of coeliac disease (CoD). At present it remains unclear whether they suffer from coeliac
gluten sensitivity (CGS) or non-coeliac gluten sensitivity (NCGS). There are specific tissue
markers of CoD such as anti-transglutaminase deposits (tTG) and intraepithelial lymphocytes
expressing T-cell receptor (TCR) gamma/delta+.
Aim: To demonstrate the existence of CGS in these patients despite having negative celiac
serology.
Methods: Double-blind randomized clinical trial of gluten vs placebo rechallenge for 6
months in patients with LE on a GFD. Inclusion criteria: >18 years, initial presentation
with GI symptoms, HLA-DQ2/8+, negative celiac serology, good clinical and histological
response to GFD. Patients were randomised to gluten (20 g/day) and placebo (maltrodextrin)
(identical powder sachets mixed with meals). Clinical symptoms were analysed using visual
analogue scales. Quality of life (GIQLI), adherence to diet, serology, and histological
changes including gamma/delta+ IEL and tTG deposits were evaluated.
Status | Completed |
Enrollment | 18 |
Est. completion date | May 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Giving written informed consent 2. Patients with age =18 years 3. Histological diagnosis confirmed of lymphocytic enteritis (LE) 4. Celiac genetic study (HLA-DQ2 and /or HLA-DQ8 positive) 5. Negative serology of celiac disease 6. Previous complete clinical and histological response to gluten-free diet 7. Initial (at diagnosis) GI symptoms with or without extraintestinal manifestations. 8. No previous studies on both IEL cytometric pattern and anti-TG2 IgA subepithelial deposits. Exclusion Criteria: 1. Patients who are unable to adhere to the study visit schedule and other protocol requirements according to the investigator. 2. Participation in a clinical trial in the last 30 days, simultaneous participation in a trial or prior participation in this study. 3. Previous diagnosis with gluten-sensitive enteropathy with villous atrophy and positive serology. 4. Patients with LE and initial response to gluten free diet but that at the time of inclusion are on a normal gluten-containing diet. 5. Severe co-morbidities. 6. Drug or alcohol abuse. 7. Pregnancy or breast-feeding. At the initial diagnosis, other LE aetiologies, like non-steroidal anti-inflammatory drugs intake, parasitic infection, and Helicobacter pylori infection, were appropriately ruled out. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Mutua de Terrassa |
Fernández-Bañares F, Carrasco A, García-Puig R, Rosinach M, González C, Alsina M, Loras C, Salas A, Viver JM, Esteve M. Intestinal intraepithelial lymphocyte cytometric pattern is more accurate than subepithelial deposits of anti-tissue transglutaminase IgA for the diagnosis of celiac disease in lymphocytic enteritis. PLoS One. 2014 Jul 10;9(7):e101249. doi: 10.1371/journal.pone.0101249. eCollection 2014. — View Citation
Molina-Infante J, Santolaria S, Sanders DS, Fernández-Bañares F. Systematic review: noncoeliac gluten sensitivity. Aliment Pharmacol Ther. 2015 May;41(9):807-20. doi: 10.1111/apt.13155. Epub 2015 Mar 6. Review. — View Citation
Rosinach M, Esteve M, González C, Temiño R, Mariné M, Monzón H, Sainz E, Loras C, Espinós JC, Forné M, Viver JM, Salas A, Fernández-Bañares F. Lymphocytic duodenosis: aetiology and long-term response to specific treatment. Dig Liver Dis. 2012 Aug;44(8):643-8. doi: 10.1016/j.dld.2012.03.006. Epub 2012 Apr 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical relapse | Visual analogue scale on clinical symptoms at each visit (Baseline, 4 weeks, 12 weeks, 24 weeks) | 6 months | No |
Secondary | Changes in health related quality of life | GI quality of life index (GIQLI) at basal and 24 week visits | Change from baseline at 6 months (or premature withdrawn) | No |
Secondary | Histological evolution (Changes in intraepithelial lymphocyte count) | Changes in intraepithelial lymphocyte count | Changes from baseline at 6 months (or premature withdrawn) | No |
Secondary | Changes in gamma/delta cells | Changes in cytometric count of gamma/delta cells | Changes from baseline at 6 months (or premature withdrawn) | No |
Secondary | Changes in transglutaminase deposits | Presence of tTG deposits (IF) | Changes from baseline at 6 months (or premature withdrawn) | No |
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