Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01762566
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, both genders, with age between 18-65 years, with gastrointestinal symptoms/signs that improved on a gluten-free diet and worsen on a wheat containing diet
* Patients testing negative for celiac disease (i.e. anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific IgE for wheat negative)
* gluten sensitivity diagnosis confirmed with a double-blind placebo-controlled challenge with gluten or placebo
Exclusion Criteria:
* Patients diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology - (presence of villi atrophy);
* Patients diagnosed with wheat allergy (positive serum specific IgE for wheat)
* Patients suffering from Diabetes Mellitus
* Patients with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
* Patients with Helicobacter pylori infection and other gastrointestinal infection
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01762566
Study Brief:
Protocol Section:
NCT01762566