Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Celiac disease (CD) is a chronic, autoimmune, multisystemic disorder caused by ingestion of gluten contained in wheat. A chronic gluten-free diet (GFD) is the only therapy for CD, however a small subgroup of patients is refractory to a GFD, in fact the pathology does not regress even with a strict diet. The microbiota plays a fundamental role in the CD, in fact, especially intestinal homeostasis requires balanced interactions between the microbiota, food antigens and the host. It is widely recognized that intestinal microbiota plays a role in the initiation and progression of intestinal inflammation in numerous chronic conditions, but recent studies have shown that even the blood microbiota plays a fundamental role in autoimmune diseases. Also microRNAs (miRNAs), RNA sequences of 20-22 non-coding nucleotides that post-transcriptionally regulate gene expression, are molecules of interest in many common diseases and therefore also in CD. Fermentable, Oligo-, Di-, Mono-saccharides And Polyol (FODMAP) are short-chain carbohydrates with poor absorption in the small intestine which increases gas production and intestinal osmolarity, which can trigger gastrointestinal symptoms in sensitive individuals. A diet low in FODMAPs is a new dietary option for the treatment of persistent gastrointestinal symptoms in celiac patients. Evaluating the effect of this type of diet on intestinal microbiota changes and miRNA expression in celiac patients with persistent gastroenterological symptoms and in patients with refractory celiac disease represents an opportunity to understand how this dietary modification could contribute to the development of this disease. 15 patients with refractory celiac disease (RCD) and 15 patients with CD responsive to the GFD between the ages of 21 and 60 will be enrolled. The aim of the research will be: 1) to characterize the intestinal, blood and duodenal microbiota, then to evaluate both the taxonomy of the identified bacteria and their relative abundance 2) to analyse the profile of miRNAs from biopsy and fibroblasts isolated in the first duodenal portion, highlighting any basal deregulation and, for fibroblasts, after treatment with the 33-mer immunogenic peptide 3) quantify and know the composition of the fecal microbiota in celiac patients with persistent symptoms and in refractory celiac patients before (T0) and after (T28) treatment with a low-FODMAP diet. The aim of the study is to observe a diversification of the microbiota pattern of refractory patients vs.#46; normoresponsive celiac patients and to observe a deregulation in the expression of miRNAs, both basally on biopsies and after treatment with the immunogenic peptide in primary fibroblast cultures.
Experimental: Low FODMAPs /balanced gluten free diet
Dietary Supplement: Balanced low FODMAPs /gluten free diet. An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.
Active Comparator: Balanced gluten free diet
Balanced gluten free diet. An expert in nutrition will give a balanced gluten free diet to patients.
Dietary Supplement: - Low FODMAPs /balanced gluten free diet
Dietary Supplement: Balanced low FODMAPs /gluten free diet
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.