Abstract
Uncertainty remains in regard to when, how, and in what form gluten should be introduced into the diet, particularly of infants genetically predisposed to developing celiac disease (CD). MEDLINE (PubMed), EMBASE, and Cochrane Central Register of Controlled Trials databases will be searched from inception. Randomized controlled trials (RCTs) and observational studies (cohort, case-control, or cross-sectional studies) investigating the association between early feeding practices and the risk of CD and/or CD autoimmunity will be included. In prospective studies, participants will be infants regardless of the risk of developing CD. For retrospective studies, participants will be children or adults with CD or presenting with positive serology indicative of CD. Interventions will be gluten-containing products of any type. Exposures will be breastfeeding and/or the introduction of gluten-containing products of any type. In control groups, there will be no exposure, different degrees of exposure (partial vs. exclusive breastfeeding, different amounts of gluten, etc.), or a placebo. The primary outcome measure will be CD or CD autoimmunity (i.e., anti-transglutaminase or anti-endomysial antibodies). At least two reviewers will independently assess the risk of bias using a validated risk assessment tool depending on study design. Disagreements will be resolved by discussion to achieve a consensus with the involvement of one or more additional reviewers if required. If appropriate, data will be pooled. If not, a narrative synthesis will be performed. The findings will be submitted to a peer-reviewed journal.
Highlights
Celiac disease (CD) is “an immune-mediated systemic disorder elicited by gluten and related prolamines in genetically susceptible individuals and characterized by the presence of a variable combination of gluten-dependent clinical manifestations, CD specific antibodies, HLA-DQ2 or HLA-DQ8 haplotypes, and enteropathy” [1,2]
Given the high prevalence and health burden of CD due to morbidity associated with the disease and because it is a permanent condition when developed [7–10], preventive strategies targeted at reducing the occurrence of CD should be considered a priority
The protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guideline (PRISMA), and the findings will be reported in line with the PRISMA guidelines [18]
Summary
Celiac disease (CD) is “an immune-mediated systemic disorder elicited by gluten and related prolamines in genetically susceptible individuals and characterized by the presence of a variable combination of gluten-dependent clinical manifestations, CD specific antibodies, HLA-DQ2 or HLA-DQ8 haplotypes, and enteropathy” [1,2]. In line with 2016 recommendations on gluten introduction and risk of CD by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) [11], gluten can be introduced into infants’ diet between the ages of 4 and 12 completed months. Neither any breastfeeding nor breastfeeding at the time of gluten introduction can be recommended as a means of reducing the risk of CD. Since the publication of the ESPGHAN guidelines, new evidence has emerged, further suggesting that the association between breastfeeding and the amount of gluten at introduction matters [12–14]. Is the risk of developing CD reduced by exclusive or any breastfeeding? Is CD development age influenced by exclusive or any breastfeeding? Type of gluten: Is CD risk influenced by the type of cereal (wheat, rye, barley) consumed at gluten introduction or later during childhood? Does the risk of developing CD differ between low- and high-risk populations (“genetic load”)?
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