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  • Jefferson Adams

    Double-Blind Placebo-Controlled Gluten Challenge Crucial for Diagnosing Non-Celiac Gluten Sensitivity in Children

    Jefferson Adams


    Reviewed and edited by a celiac disease expert.

      The gluten challenge was considered positive when accompanied by a minimum 30% decrease of global visual analogue scale between gluten and placebo.


    Caption: Photo: CC--Jamie

    Celiac.com 03/05/2018 - While people with non-celiac gluten sensitivity (NCGS) have neither celiac disease nor wheat allergy (WA), they often do have intestinal and extra-intestinal symptoms that are related to gluten consumption.

    Using a double-blind placebo-controlled (DBPC) gluten challenge with crossover, a team of researchers recently set out to conduct the first assessment of NCGS rates in children with chronic, gluten-associated gastrointestinal symptoms.



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    The research team included R Francavilla MD, PhD, F Cristofori MD, L Verzillo MD, A Gentile MD, S Castellaneta MD, C Polloni MD, V Giorgio MD, E Verduci MD, PhD, E D'Angelo MD, S Dellatte MD & F Indrio MD. They are variously affiliated with the Department of Pediatrics, San Paolo Hospital, Bari Italy; the Department of Pediatrics, Santa Maria del Carmine Hospital, Rovereto TN, Italy; the Department of Pediatrics, Catholic University, Rome, Italy; the Department of Pediatrics, University of Milan, S. Paolo Hospital, Milan, Italy; the Department of Pediatrics, Santa Maria Incoronata dell’Olmo Hospital; Cava dei Tirreni SA, Italy; the Tandoi Group Factory, Corato, Italy; and the Interdisciplinary Department of Medicine-Pediatric Section, University of Bari, Bari, Italy.

    Their team looked at 1,114 children with chronic gastrointestinal symptoms, but no celiac disease and WA. For children showing a positive connection between symptoms and gluten ingestion, the team offered a four-stage diagnostic challenge that included: run-in, open gluten-free diet (GFD) and DBPC crossover gluten challenge.

    Patients randomly received gluten (10 g/daily) and placebo (rice starch) for 2 weeks each, separated by a washout week. The gluten challenge was considered positive when accompanied by a minimum 30% decrease of global visual analogue scale between gluten and placebo.

    Out of 1,114 children, 96.7% showed no correlation with gluten ingestion. Thirty-six children were eligible for the diagnostic challenge. After the run-in and open GFD, 28 patients underwent gluten challenge. Eleven of these children tested positive (39.2%).

    This is the first such study to demonstrate the need for a DBPC for diagnosing NCGS in children, since the diagnosis is ruled out in more than sixty-percent of cases.

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,500 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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