A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease.
Am J Clin Nutr
; 85(1): 160-6, 2007 Jan.
Article
en En
| MEDLINE
| ID: mdl-17209192
ABSTRACT
BACKGROUND:
Treatment of celiac disease (CD) is based on the avoidance of gluten-containing food. However, it is not known whether trace amounts of gluten are harmful to treated patients.OBJECTIVE:
The objective was to establish the safety threshold of prolonged exposure to trace amounts of gluten (ie, contaminating gluten).DESIGN:
This was a multicenter, double-blind, placebo-controlled, randomized trial in 49 adults with biopsy-proven CD who were being treated with a gluten-free diet (GFD) for > or =2 y. The background daily gluten intake was maintained at < 5 mg. After a baseline evaluation (t0), patients were assigned to ingest daily for 90 d a capsule containing 0, 10, or 50 mg gluten. Clinical, serologic, and histologic evaluations of the small intestine were performed at t0 and after the gluten microchallenge (t1).RESULTS:
At t0, the median villous height/crypt depth (Vh/Cd) in the small-intestinal mucosa was significantly lower and the intraepithelial lymphocyte (IEL) count (x 100 enterocytes) significantly higher in the CD patients (Vh/Cd 2.20; 95% CI 2.11, 2.89; IEL 27; 95% CI 23, 34) than in 20 non-CD control subjects (Vh/Cd 2.87; 95% CI 2.50, 3.09; IEL 22; 95% CI 18, 24). One patient (challenged with 10 mg gluten) developed a clinical relapse. At t(1), the percentage change in Vh/Cd was 9% (95% CI 3%, 15%) in the placebo group (n = 13), -1% (-18%, 68%) in the 10-mg group (n = 13), and -20% (-22%, -13%) in the 50-mg group (n = 13). No significant differences in the IEL count were found between the 3 groups.CONCLUSIONS:
The ingestion of contaminating gluten should be kept lower than 50 mg/d in the treatment of CD.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Enfermedad Celíaca
/
Glútenes
/
Mucosa Intestinal
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Adult
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Am J Clin Nutr
Año:
2007
Tipo del documento:
Article
País de afiliación:
Estados Unidos