Safety for patients with celiac disease of baked goods made of wheat flour hydrolyzed during food processing.
OBJECTIVE
Celiac disease (CD) is characterized by an inflammatory response to wheat gluten, rye, and barley proteins. Fermentation of wheat flour with sourdough lactobacilli and fungal proteases decreases the concentration of gluten. We evaluated the safety of daily administration of baked goods made from this hydrolyzed form of wheat flour to patients with CD.


METHODS
Patients were randomly assigned to consumption of 200 g per day of natural flour baked goods (NFBG) (80,127 ppm gluten; n = 6), extensively hydrolyzed flour baked goods (S1BG) (2480 ppm residual gluten; n = 2), or fully hydrolyzed baked goods (S2BG) (8 ppm residual gluten; n = 5) for 60 days.


RESULTS
Two of the 6 patients who consumed NFBG discontinued the challenge because of symptoms; all had increased levels of anti-tissue transglutaminase (tTG) antibodies and small bowel deterioration. The 2 patients who ate the S1BG goods had no clinical complaints but developed subtotal atrophy. The 5 patients who ate the S2BG had no clinical complaints; their levels of anti-tTG antibodies did not increase, and their Marsh grades of small intestinal mucosa did not change.


CONCLUSIONS
A 60-day diet of baked goods made from hydrolyzed wheat flour, manufactured with sourdough lactobacilli and fungal proteases, was not toxic to patients with CD. A combined analysis of serologic, morphometric, and immunohistochemical parameters is the most accurate method to assess new therapies for this disorder.
Department of Pediatrics and European Laboratory for the Study of Food Induced Diseases, University of Naples, Federico II, Naples, Italy. ydongre@unina.it
Luigi
L
Greco
Marco
M
Gobbetti
Renata
R
Auricchio
Raffaella
R
Di Mase
Francesca
F
Landolfo
Francesco
F
Paparo
Raffaella
R
Di Cagno
Maria
M
De Angelis
Carlo Giuseppe
CG
Rizzello
Angela
A
Cassone
Gaetano
G
Terrone
Laura
L
Timpone
Martina
M
D'Aniello
Maria
M
Maglio
Riccardo
R
Troncone
Salvatore
S
Auricchio
D000293:Adolescent; D000906:Antibodies / Q000097:blood; D002446:Celiac Disease / Q000628:therapy*; D002648:Child; D004035:Diet Therapy / Q000009:adverse effects*; D004797:Enzyme-Linked Immunosorbent Assay; D005433:Flour; D005511:Food Handling / Q000379:methods*; D005524:Food Technology / Q000379:methods*; D005658:Fungi / Q000378:metabolism; D005983:Glutens / Q000378:metabolism*; D006801:Humans; D006868:Hydrolysis; D007070:Immunoglobulin A / Q000097:blood; D007150:Immunohistochemistry; D007778:Lactobacillus / Q000378:metabolism; D010447:Peptide Hydrolases / Q000378:metabolism; D014908:Triticum / Q000737:chemistry*; D055815:Young Adult
D000906:Antibodies; D007070:Immunoglobulin A; D005983:Glutens; D010447:Peptide Hydrolases