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 - 70 Years|
- - a gluten-containing diet for at least six months before enrollment
- anti-transglutaminase antibodies (IgA and IgG) absence
- normal serum IgA levels
- prick and specific IgE tests for wheat allergy negative
Exclusion Criteria:- celiac disease - wheat allergy - chronic intestinal inflammatory diseases - psychiatric disorders - major abdominal surgery (in particular intestinal resections) - diabetes mellitus - previous anaphylactic episodes - gluten-free diet in the previous six months - pregnant or lactating women.
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.
|University of Bari|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||University of Bari|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Non-celiac Gluten Sensitivity, Irritable Bowel Syndrome|
Study design: For this study, patients with diagnosis of IBS performed by Rome IV criteria and followed as outpatients at the Clinical Nutrition Clinic of "Petrucciani" Nursing Home of Lecce (LE), Italy, will be enrolled. At baseline, the enrolled subjects will follow a balanced normal-caloric low-FODMAP and gluten-free diet for a period of 30 days. At the end of the 30 days patients who did not experience an improvement in symptoms will be considered "non-responders" and discontinue the clinical trial. Only those subjects who had showed a significant improvement in symptoms, will be enrolled for the phase 2 of the study that includes a challenge with gluten or with placebo, as described by the Salerno criteria.
Active Comparator: patients with IBS treated with gluten
patients receiving flour with gluten (nocebo)
Placebo Comparator: patients with IBS treated with placebo
patients receiving gluten-free flour (placebo)
Dietary Supplement: - diet containing gluten
gluten-free flour (placebo) will be added for 5 days to the low FODMAP diet. After 1 week of wash-out, patients will switch to flour with gluten (nocebo) for another 5 days
Dietary Supplement: - Placebo
Contact a Trial Team
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.