Objective Evaluate in patients with celiac disease the tolerance of pr
olonged consumption of small amounts of gliadin contained in products
containing wheat starch. Design Open 1-year trial of the addition of w
heat starch to a gluten-free diet in a cohort of adult patients with b
iopsy-proven celiac disease who had never consumed wheat starch. The c
ontrol group consisted of patients with celiac disease who tolerated w
heat starch. Subjects Seventeen patients with celiac disease and 14 co
ntrol patients, all diagnosed according to criteria of the European So
ciety of Pediatric Gastroenterology and Nutrition, were recruited from
the Canadian Celiac Association and the Quebec Celiac Foundation. Set
ting The study was conducted in the outpatient clinic of the Gastroent
erology and Nutrition Service of Ste Justine Hospital, Montreal, Quebe
c, Canada. Interventions Patients were asked to consume four to six po
rtions daily of a wheat starch-containing product, mainly bread, for u
p to 1 year. Main outcome measures The gliadin content of the wheat st
arch product used in this trial was quantified by enzyme-linked immuno
sorbent assay. Patient outcome measures included symptoms, nutritional
parameters (anthropometric data, complete blood count, serum folate a
nd iron levels), and immunologic parameters (antigliadin antibody and
antiendomysium antibody titers). Results A quantifiable amount of immu
noreactive gliadin (0.75 mg/100 g) was found in the wheat starch. The
majority of the patients with celiac disease (11 of 17) who had never
consumed wheat starch previously developed symptoms, which resolved wi
thin weeks of discontinuing the product. Relapse of skin lesions was s
een in two of three patients with coexisting dermatitis herpetiformis.
No weight loss or biochemical changes were observed. Despite the pres
ence of symptoms, antigliadin antibody and antiendomysium antibody det
erminations were not useful to detect the clinical intolerance. Applic
ations The innocuousness of the long-term ingestion of ''gluten-free''
products containing wheat starch is still unproven, and prolonged use
of such products by patients with celiac disease cannot be recommende
d.