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Celiac.com 06/11/2015 - Non-celiac gluten sensitivity (NCGS) is a somewhat controversial emerging disorder. There is no current medical consensus regarding its criteria, and study data have been inconclusive. Many alternative health practitioners recommend gluten-free diets for people who claim to be sensitive to gluten, but do not have celiac disease. Despite numerous reports of people without celiac disease experiencing celiac-like symptoms when eating gluten, there are currently no clear diagnostic guidelines for NCGS. NCGS is still diagnosed by excluding celiac disease, and finding no reliable celiac biomarkers. A team of researchers recently set out to evaluate the prevalence, diagnostic exclusion of celiac disease and the efficacy of a gluten-free diet (GFD) for NCGS patients. The research team included J. Molina-Infante; S. Santolaria; D. S. Sanders; and F. Fernández-Bañares. They are variously affiliated with the Department of Gastroenterology, Hospital San Pedro de Alcantara, Caceres, Spain, the Department of Gastroenterology, Hospital San Jorge, Huesca, Spain, the Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK, the Department of Gastroenterology, Hospital Universitario Mutua Terrassa, Barcelona, Spain, and with CIBERehd, Barcelona, Spain. Their team conducted a PubMed search through December 2014. They defined NCGS as self-reported gluten intolerance, negative celiac serology and absence of villous atrophy. They also included studies evaluating the impact of a GFD on patients with irritable bowel syndrome (IBS). They found that rates of NCGS (0.5–13%) varied considerably. Seventeen studies met the inclusion criteria for NCGS. The studies included 1561 patients, 26 of whom were children. HLA haplotypes could not be linked to histology, either by normal or lymphocytic enteritis (LE)] in 1,123 NCGS patients. Nearly half (44%) of NCGS patients tested positive for HLADQ2/DQ8 haplotypes. Using advanced diagnostic techniques that combine LE and HLADQ2/DQ8 haplotypes, the team reclassified 39 (20%) of 189 NCGS cases as celiac disease. They found a higher than expected family history of celiac disease and autoimmune disorders in NCGS patients. For HLADQ2 positive diarrhea-predominant IBS patients, a GFD resulted in variable, but significantly improved stool frequency. Rates of NCGS are extremely variable. A subset of NCGS patients might actually be part of what many researchers refer to as celiac disease "light." The long term benefit of a gluten-free diet for NCGS patients is currently unclear, but certainly the diet, if well-balanced, would not cause any issues. The researchers do note that HLADQ2 positive diarrhea-type IBS patients might gain symptom improvement from a gluten-free diet. Clearly more studies are needed to determine if NCGS is a bona fide medical condition, as many suspect. Until then, there is very little treatment available from medical practitioners, and many people with self-diagnosed NCGS will doubtless be left to self-treatment. For many, this will include avoiding gluten. Do you, a loved one, or someone you know have gluten-sensitivity without celiac disease? Share your thoughts and comments below. Source: Aliment Pharmacol Ther. 2015;41(9):807-820.
Celiac.com 12/09/2014 - Biopharmaceutical company BioLineRx Ltd., has announced successful final results from its Phase 1/2 study for BL-7010, a novel co-polymer for the treatment of celiac disease. BL-7010 is a new, non-absorbable, orally available co-polymer intended for the treatment of celiac disease. The drug works by sequestering gliadins, effectively masking them from enzymatic degradation and preventing the formation of immunogenic peptides that trigger an adverse immune reaction when people with celiac disease consume wheat. This significantly reduces the immune response triggered by gluten. BL-7010 is excreted with gliadin from the digestive tract and is not absorbed into the blood. The trial results showed BL-7010 to be safe and well tolerated in both single- and repeated-doses, and pharmacokinetic analyses revealed no systemic exposure of BL-7010 in plasma and urine samples. The company has also settled on a one gram, three times per day regimen of BL-7010 as the optimal repeated dose for an upcoming randomized, placebo-controlled efficacy study set to begin in the last half of 2015. The absence of systemic exposure will likely support a medical-device classification for BL-7010, which would significantly accelerate its development in Europe. Source: Marketwatch.com