Jump to content



Celiac.com Sponsor (A1):



Celiac.com Sponsor (A1-m):


  • You've found your Celiac Tribe! Join our like-minded, private community and share your story, get encouragement and connect with others.

    💬

    • Sign In
    • Sign Up
  • Jefferson Adams
    Jefferson Adams

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

    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.

    Double-Blind Placebo-Controlled Gluten Challenge Crucial for Diagnosing Non-Celiac Gluten Sensitivity in Children - Photo: CC--Jamie
    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.



    Celiac.com Sponsor (A12):






    Celiac.com Sponsor (A12-m):




    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.

    Source:


    User Feedback

    Recommended Comments

    There are no comments to display.



    Join the conversation

    You are posting as a guest. If you have an account, sign in now to post with your account.
    Note: Your post will require moderator approval before it will be visible.

    Guest
    Add a comment...

    ×   Pasted as rich text.   Restore formatting

      Only 75 emoji are allowed.

    ×   Your link has been automatically embedded.   Display as a link instead

    ×   Your previous content has been restored.   Clear editor

    ×   You cannot paste images directly. Upload or insert images from URL.


  • About Me

    Jefferson Adams

    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.


  • Celiac.com Sponsor (A17):
    Celiac.com Sponsor (A17):





    Celiac.com Sponsors (A17-m):




  • Related Articles

    Jefferson Adams
    Celiac.com 11/11/2015 - If you ask me, it doesn't seem that far-fetched that some people who do not have celiac disease could still have adverse reactions to gluten. However, actually proving that scientifically continues to be challenging.
    Take the case of the research team that recently conducted a double-blind, placebo-controlled, cross-over, gluten-challenge trial of patients with suspected non-celiac gluten sensitivity. The team wanted to try to get an idea of the number of self-diagnosed patients with non-celiac gluten sensitivity.
    The team enrolled 53 women and 8 men referred to two Italian centers between October 2012 and November 2013 for suspected non-celiac gluten sensitivity. The subjects were randomly assigned to receive 4.375-g gluten or rice starch per day via gastro-soluble capsules for 1 week after a 1-week run-in period, and followed by a 1-week washout period and cross-over to the other group.
    The team chose rice starch as the placebo because it is "the most readily absorbable of the complex carbohydrates, and thus less fermentable, in the intestinal tract." They used a daily questionnaire to chart any changes in overall symptom scores, and conducted analysis with a per-protocol approach. A total of 59 patients completed the trial, while two withdrew due to "intolerable symptoms."
    Overall, one week of gluten consumption increased overall symptom severity compared with one week of placebo (P = .034), including abdominal bloating (P = .04), abdominal pain (P = .047), foggy mind (P = .019), depression (P = .02) and aphthous stomatitis (P = .025).
    Perplexingly, the team found that "most patients showed approximately equal degrees of overall symptoms with either gluten or placebo, although overall symptoms were worsened significantly by gluten in comparison with placebo."
    Got that? Significant numbers of the subjects reacted to the placebo.
    The short conclusion is that these results "do not represent crucial evidence in favor of the existence of this new syndrome." However, and it's a big however, the results aren't quite as clear as they might appear.
    In an accompanying editorial, Benjamin Lebwohl, MD, from the Celiac Disease Center at Columbia University, and Daniel A. Leffler, MD, MS, from Beth Israel Deaconess Medical Center write:
    The "overall positive result was driven by a minority of patients, whereas the rest had no (or at most a modest) worsening compared with placebo."
    They add that:
    "These findings can be a Rorschach test of sorts, in which the viewer draws interpretations that are based on his or her prior beliefs about NCGS. … It is therefore not surprising that this trial, like its predecessors, seems only to contribute to the uncertainty about NCGS."
    So, basically, there's no clear word on the existence or non-existence of non-celiac gluten sensitivity, or on the number of people who might suffer from it.
    Stay tuned for more studies, and more information as researchers attempt to sort it all out.
    Source:
    CGHJournal.org


    Jefferson Adams
    Celiac.com 06/13/2016 - Researchers Umberto Volta, Giacomo Caio, and Roberto De Giorgio, of the Department of Medical and Surgical Sciences at the University of Bologna in Bologna, Italy, recently submitted a letter to the medical journal Gastroenterology.
    In their letter, the researchers respond to a recent paper, published by Carroccio et al, reporting on the prevalence of autoimmunity (as identified by positivity of antinuclear antibodies [ANA] and associated autoimmune disorders) in non-celiac wheat sensitivity (NCWS) compared with celiac disease and irritable bowel syndrome (IBS). They note that the study results, based on retrospective and prospective data, showed that the prevalence of ANA in NCWS was significantly higher than in celiac disease and IBS (46% in NCWS vs 24% in celiac disease and 2% in IBS, retrospectively; and 28% in NCWS vs 7.5% in celiac disease and 6% in IBS, prospectively).
    They note also that both retrospective and prospective analysis show autoimmune disorders (mainly autoimmune thyroiditis) in a slightly higher proportion in NCWS (29% vs 24%) than celiac disease (21% vs 20%). Meanwhile, both NCWS and celiac patients showed substantially higher rates of autoimmune disorders than IBS. In both both retrospective and prospective data, ANA showed a strong relation to HLA-DQ2 and -DQ8 in NCWS, whereas these autoantibodies were associated with autoimmune disorders only in the prospective arm.
    The team found these results from the Carroccio study to be scientific interesting because NCWS, more than better known autoimmune disorders, such as celiac disease, shows a surprisingly high autoimmune profile. They note that celiac disease is a well-established autoimmune condition often marked by different types of autoantibodies and associated autoimmune disorders. Such autoimmune features have not been seen so far in NCWS and the odds of these patients developing autoimmune dysfunction remains unknown.
    The team's data showed that only 14% of 486 patients with NCWS had an associated autoimmune disorder including thyroiditis, psoriasis, Graves disease, type 1 diabetes mellitus, and atrophic gastritis. In contrast, about 30% of 770 celiac patients showed the same autoimmune manifestations. These findings are in line with previously published data.
    They point out that another interesting aspect that came out of Carroccio study is the very high rate of ANA in their cohort of NCWS versus celiac disease and IBS patients. The team notes that their own experience shows ANA to be higher in celiac disease than NCWS and IBS (49% vs 37% vs 6%), which indicates a substantial autoimmune profile in celiac disease, compared with the two other conditions. They also note that evidence showing patients with NCWS to have higher rates of ANA compared with IBS is in line with the results presented by Carroccio et al.
    They conclude their letter by stating that consistent evidence supports a major role of adaptive immunity in celiac disease more than NCWS, and this peculiarity is reflected by a predominant occurrence of autoimmune disorders and autoantibodies (eg, ANA).
    However, the challenging data shown by Carroccio et al provide the basis to understand whether NCWS, like celiac disease, show a wide array of autoimmune expressions mediated by adaptive mechanisms.
    They call for further studies to better understand what they term the "intriguing relationship between autoimmunity and NCWS."
    Source:
     Gastroenterology. 2016 Jan;150(1):282. doi: 10.1053/j.gastro.2015.08.058. Epub 2015 Nov 23.


    Jefferson Adams
    Celiac.com 09/12/2016 - Wheat gluten and related proteins can trigger an autoimmune enteropathy, known as celiac disease, in people with genetic susceptibility. However, some people experience a range of gluten reaction symptoms, but without the classic blood or gut markers for celiac disease. The etiology and mechanism of these symptoms are unknown, and so far, researchers have found no biomarkers to explain the issue.
    A research team recently set out to determine if sensitivity to wheat in the absence of celiac disease is associated with systemic immune activation that may be linked to some type of enteropathy. The research team included Melanie Uhde, Mary Ajamian, Giacomo Caio, Roberto De Giorgio, Alyssa Indart, Peter H Green, Elizabeth C Verna, Umberto Volta, and Armin Alaedini. They are variously affiliated with the Celiac Disease Center and the Department of Medicine at Columbia University Medical Center, New York, New York, USA, Departments of Medical and Surgical Sciences and Digestive System, Centro di Ricerca Biomedica Applicata (C.R.B.A.), University of Bologna, St. Orsola-Malpighi Hospital, Bologna, Italy, and the Institute of Human Nutrition at Columbia University Medical Center, New York, New York, USA.
    The study included a group of healthy control subjects, patients with clinical celiac disease, and patients who reported symptoms after wheat consumption, but in whom doctors had ruled out celiac disease and wheat allergy.
    The team analyzed test samples for markers of intestinal cell damage and systemic immune response to microbial components. Patients with wheat sensitivity showed sharply increased serum levels of soluble CD14 and lipopolysaccharide (LPS)-binding protein, as well as antibody reactivity to bacterial LPS and flagellin. Circulating levels of fatty acid-binding protein 2 (FABP2), a marker of intestinal epithelial cell damage, were much higher in the affected individuals, and correlated with the immune responses to microbial products.
    Patients with wheat sensitivity who observed a gluten-free diet saw levels of FABP2 and immune activation markers move rapidly toward normal.
    These findings show a state of systemic immune activation, coupled with a compromised intestinal epithelium, that triggers gastrointestinal symptoms in certain individuals who have wheat sensitivity, but don't have celiac disease.
    Source:
    Gut. doi:10.1136/gutjnl-2016-311964


    Jefferson Adams
    Celiac.com 08/23/2017 - A team of researchers recently set out to assess how many patients with a diagnosis of non-celiac wheat sensitivity (NCWS) still experienced symptoms of wheat sensitivity after an average follow-up time of 99 months.
    The research team included Antonio Carroccio, Alberto D’Alcamo, Giuseppe Iacono, Maurizio Soresi, Rosario Iacobucci, Andrea Arini, Girolamo Geraci, Francesca Fayer, Francesca Cavataio, Francesco La Blasca, Ada M. Florena, and Pasquale Mansueto.
    Using data collected from 200 participants from a previous study of non-celiac wheat sensitivity, performed between July and December 2016 in Italy, the team found that 148 of these individuals still followed a strict wheat-free diet.
    In total, 175 patients (88%) said that they had fewer symptoms after a diagnosis of non-celiac wheat sensitivity and general improvement.
    Of the 148 patients who adhered strictly to a gluten-free diet, 145 (98%) had reduced symptoms, compared with 30 of 52 patients who did not adhere to a gluten-free diet (58%) (P < .0001).
    Of the 22 patients who repeated the double-blind, placebo-controlled challenge, 20 reacted to wheat.
    The numbers and percentages of the 148 non-celiac wheat sensitivity patients on a strict wheat-free diet who reported that the following symptoms recurred after occasional and accidental wheat consumption: Lack of well-being 135 (91%); Tiredness 102 (69%); Foggy mind 68 (46%); Menstrual alterations 54 (36%); Anemia 46 (31%); Weight increase 45 (30%); Joint/muscle pain 35 (24%); Headache 31 (21%); Weight loss 30 (20%); Anxiety 18 (12%); Skin rash 16 (11%); Recurrent cystitis 12 (8%); Depression 10 (7%).
    From these numbers, the team concludes that non-celiac wheat sensitivity is a persistent condition.
    Clinicaltrials.gov registration number: NCT02823522.
    Source:
    Gastroenterology. DOI: http://dx.doi.org/10.1053/j.gastro.2017.03.034


  • Popular Now

×
×
  • Create New...