Clinical Research Directory

GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease

The aim of this cross-sectional observational study is to comprehensively examine the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. In this context, dual-task gait performance, cognitive processing speed and attention, working memory and executive functions, muscle strength, quality of life, and fatigue levels of individuals with celiac disease who are adherent or non-adherent to a gluten-free diet will be compared with those of healthy peers. In addition, sleep patterns, pubertal development, socioeconomic indicators, and serological markers will be taken into account to evaluate the unique effects of diet adherence on neurocognitive and functional outcomes. All assessments will be conducted in accordance with a predefined standardized protocol. The order of measurement instruments will be randomized to minimize potential bias. Inclusion criteria will consist of being between 8 and 18 years of age, having a celiac disease diagnosis confirmed by serology, being followed with this diagnosis for at least six months, and obtaining written informed consent from both the participant and their parent/guardian. For the healthy control group, participants must be within the same age range and have no history of chronic neurological, psychiatric, or gastroenterological conditions. Data analysis will be performed using SPSS

Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research

The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.

Eating Behaviors in Children and Adolescents With/Without Celiac Disease

This observational study investigates the prevalence and severity of disordered eating behaviors in adolescents aged 11-17 years with celiac disease. Participants complete validated self-report questionnaires (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination Questionnaire, PEDE-Q) and a structured clinical form. A healthy control group, matched by age and sex, is included for comparison. A longitudinal sub-cohort diagnosed with celiac disease \<6 months prior will be followed at 6, 12, and 24 months to evaluate changes in eating psychopathology and associated clinical variables.

Dietary Intervention Using a Gluten-free App to Improve Tracking, Adherence, and Learning(DIGITAL) Study

With rising incidence of celiac disease(CeD) (3% of population), there is an urgent need for practical, efficient and usable application that can feedback to families and providers about their ultra-processed gluten-free food (UPGFF) consumption as well as to help families identify where they may be having unintentional gluten exposure. The investigators propose to use MyMedDiary, a researcher driven platform dedicated to streamline and enhance dietary data collection, to first validate that it can accurately and efficiently identify gluten-free foods which are ultra-processed. The investigators aim to provide feedback to families on potential sources of gluten exposure as they transition to a gluten-free diet(GFD).

Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease

Although a gluten-free diet (GFD) is essential for patients with coeliac disease (CD), many do not follow it strictly. Exposure to gluten causes villous atrophy, can deteriorate nutritional status, and can lead to deficiencies. The ESPGHAN recommends combining multiple methods to assess GFD adherence. The Celiac Dietary Adherence Test (CDAT) and measuring the gluten immunogenic peptide in urine (uGIP) or stool (sGIP) were suggested. This study aims to evaluate and compare the usefulness of an adapted CDAT, the rapid tests for detecting uGIP and sGIP, for assessing adherence to a GFD in children with CD. Additionally, we will assess these children's nutritional status. Patients, aged 2-18 years, diagnosed with CD, who have been on a GFD for at least 6 months, will be included. Clinical characteristics and anthropometric measurements will be recorded. The adapted CDAT form will be applied. A single urine and stool samples will be collected immediately, and rapid tests for the detection of GIP will be performed. The serum levels of anti-transglutaminase antibodies (IgA), albumin, ferritin, folate, vitamins B12, A, E, 25-OH vitamin D, blood count and lipid profile will be measured.

Validation of the CDAT in the Polish Paediatric Population

The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants). The Polish translation will be performed by two native bilingual speakers of Polish and English. Both translations will be compared and standardised. The Polish version will then be translated into English by two native bilingual speakers of English who are unfamiliar with the original English version. The translation and original will be compared to clarify discrepancies and ensure conceptual equivalence between the versions. The agreed-upon translation will be culturally adapted, if necessary. The items will be reviewed by five experts, and an I-CVI of at least 0.78 will be considered satisfactory content validity. In the next step, 10 coeliac disease (CD) patients aged 10 years and older and 10 caregivers/parents of CD patients under 10 years of age will be asked to rate the clarity of each statement on a Likert scale \[1 = unclear to 5 = very clear\]. Questions with a mean score \<4.0 will be rephrased and re-evaluated. Internal consistency analysis using Cronbach's alpha and the mean inter-item correlation (AIC) will be used to assess reliability. Convergent validity will be assessed by comparing scale scores with serological marker levels. Confirmatory factor analysis (CFA) will be conducted, taking into account the SRMR fit index.

Prevention of Celiac Disease in Skåne

This study aims to investigate the impact of being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children. This is a three-arm (1:1:1) randomized trial where study participants are randomly allocated to one of the three study groups before the age of 4 months. Regular clinical visits (4 times/year) during the intervention phase and yearly there after, up to the age of 7 years.

Gluten Reduction and Risk of Celiac Disease

Celiac disease shares many features of other autoimmune diseases such as type 1 diabetes. Recently, it was published that higher amounts of gluten intake increased the risk for celiac disease. Optimal amounts of gluten to be introduced during weaning have not yet been established. The aim is to investigate if a gluten-restricted diet (e.g. below 3 gram per day) during the first 3 years of life will reduce the risk of develop CDA and IA in genetically predisposed children by the age of 7 years. Children who screened positive for HLA DQ2/X (X is neither DQ2 nor DQ8) in the GPPAD-02 (ASTR1D \[ClinicalTrials.gov Identifier NCT03316261\]) screening will be contacted by a study nurse.

Immune Responses to Gluten

This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

Supporting Children and Young People to Live Well With Coeliac Disease: A RCT

Managing a strict gluten-free diet is crucial for children and young people with coeliac disease. However, this can have adverse effects on psychological well-being and quality of life. Despite appeals from families, clinicians, and researchers, psychological support is not routinely provided to these families. A feasibility project (NCT06007898) adapted existing self-help psychological resources used for food allergy, gastrointestinal disease, and type one diabetes to cater to families dealing with coeliac disease. This feasibility randomised controlled trial was conducted with 100 families and highlighted the viability and acceptability of this self-help resource. This pilot study was conducted in consultation with caregiver(s), clinicians, and CYP living with coeliac disease. These consultations confirmed a lack of support in this area and the enthusiasm for self-help psychological interventions. We will now run a full randomised controlled trial to evaluate the effectiveness of the intervention for caregiver(s) of CYP with coeliac disease in supporting the appropriate management of the gluten-free diet, alongside psychological wellbeing. For this trial, 172 families will complete well-being and quality of life questionnaires, along with assessments of their child's gluten-free dietary management. Families will be divided into groups receiving the psychological resources either immediately or after a five-month delay. Follow-up questionnaires will be administered at one, two, and five months for all families, regardless of intervention access. Feedback on the resources and research participation will be gathered. The expectation is that these self-help psychological resources for parents will enhance gluten-free diet management, quality of life for coeliac children and young people, and well-being for parents.

Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial

This study aims to understand how to best manage iron deficiency in children newly diagnosed with celiac disease. Many children with celiac disease have low iron levels, even if they do not have anemia. While some doctors recommend iron supplements, others believe that simply following a gluten-free diet may be enough to restore iron levels naturally. In this study, children with newly diagnosed celiac disease and low iron levels (but normal hemoglobin) will be randomly assigned to one of two groups: Gluten-Free Diet Only - No additional iron supplements Gluten-Free Diet + Iron Supplementation Researchers will compare iron store levels over one year to see if iron supplements provide any additional benefit beyond the gluten-free diet alone. The study will also track possible side effects of iron supplements, such as stomach discomfort. This study will help doctors determine the best approach to managing iron deficiency in children with celiac disease, ensuring they receive the safest and most effective treatment.

Clinical Association Between Celiac Disease and Intussusception in Children

Clinical association Between Celiac Disease and Intussusception in children

Liver Steatosis in Pediatric CD Patients

Celiac disease (CD) is an autoimmune enteropathy triggered by the intake of gluten, characterized by a genetic predisposition. Although, CD is often associated with malabsorption symptoms, a growing number of affected subjects are overweight or frankly obese. One of the conditions that is most frequently detected in pauci/asymptomatic subjects is an increase in transaminases, which often regresses completely after the start of GFD. More recently, a specific liver disorder has shown a certain relevance in adult patients suffering from CD, so much so that the European Society for the Study of Coeliac Disease (ESsCD) has cited it among the possible comorbidities which should be screened in CD subjects: Non-Alcoholic Fatty Liver Disease (NAFLD). In adults, a non-random association between CD and NAFLD has been demonstrated, showing a CD prevalence rate of 2-14% among patients with NAFLD. Few studies have focused on this same aspect in pediatric age, reporting contrasting data. Several factors have been advocated as putative responsible of association between CD and NAFLD: dietary imbalances, intestinal mucosa permeability impairment, alterations of the intestinal microbiota. The objectives of this study are: 1. define, retrospectively, the prevalence of NAFLD in a pediatric population affected by CD and study its possible association with GFD. 2. define the possible role of the intestinal permeability alteration and/or the intestinal mucosa damage and/or the proinflammatory status in the development of NAFLD in children affected by CD.

Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease

Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.

Celiac Disease in Childhood-Adulthood Transition

Aims of this study are to evaluate adolescents with celiac disease during their transition from pediatrics to adult care, and to develop better healthcare follow-up practices.

Prevention av Autoimmunitet Med Laktobaciller

The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. There is currently no cure for autoimmune diseases, but the treatment is lifelong and either involves suppressing the inflammation and / or substituting the organs that are affected to maintain vital functions. Being able to predict who is affected and identifying factors that trigger autoimmunity is necessary for developing new treatment methods that prevent the occurrence of autoimmune diseases. The bacterial flora's composition in the gut can affect both the intestinal barrier properties and the immune system's response to various dietary components. An adverse composition of the intestinal flora can activate parts of the immune system that are involved in chronic inflammation in celiac disease and inflammatory bowel disease. Probiotics are defined as living microorganisms which, when ingested in sufficient amounts, produce a health effect (FAO / WHO). The aim of the study is to investigate whether a daily oral intake of a mixture of L.paracasei and L.plantarum can affect the autoimmune process in children who are screened positive for any of the autoantibodies associated with development of celiac disease, type 1 diabetes and / or thyroid disease. Our hypothesis is that lactobacilli can directly regulate the autoimmune process in the small intestinal mucosa by stimulating regulatory T-cells, but also by affecting the permeability of the small intestinal mucosa by of antigen that stimulates specific T-cells.

Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)

Celiac disease is a disorder commonly diagnosed during childhood. The treatment is a lifelong gluten-free diet. Both the condition and the diet can influence the children's physical and emotional well-being. The main goal of this observational study is to learn about nutritional status in a group of children with celiac disease compared to a group of healthy children. The nutritional assessment includes information on diet, biochemical measurement, and body composition. Quality of life will also be assessed. The study can contribute to ensure good health and well-being in children on a gluten-free diet.

Entities and Variables Related to Catch-up Growth

A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned.

Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease

Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut. However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain. CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy). The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays. In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay).

Development of CELIAC-Q KIDS: A Patient-Reported Outcome Measure for Pediatric Celiac Disease

A multicentre, prospective observational study to develop the CELIAC-Q KIDS patient reported outcome measure for children and adolescents with celiac disease. The CELIAC- Q KIDS will contain a comprehensive set of independently functioning scales designed to measure outcomes that matter to children with celiac disease, as well as scales to measure patients experience with the gluten-free diet.