NCT01762579 Bio-markers of Not-celiac Wheat Sensitivity
| NCT ID | NCT01762579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Palermo |
| Condition | Not-celiac Wheat Sensitivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2012-01-01 |
| Primary Completion | 2016-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2012-01-01 with a primary completion date of 2016-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the investigators' study is to evaluate biochemical, immunological and histological characteristics of patients affected with the so-called "gluten (or wheat) sensitivity" who suffers from irritable bowel syndrome (IBS)-like symptoms. As it is not known what component of the cereals causes the symptoms in so called "gluten-sensitive" patients, the investigators prefer to speak of "not-celiac wheat sensitivity" (NCWS). NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat consumption, that improved on wheat/gluten free diet (GFD). For our research, we will select adult patients, both genders, affected with suspected NCWS (i.e. with symptoms/signs which disappeared on GFD and worsen on a gluten containing diet, testing negative for celiac disease \[anti-tissue transglutaminase antibodies, anti-tTG, and anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1\] and wheat allergy \[serum specific IgE for wheat\]). The patients will be recruited at the Department of Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of the University of Palermo, from January 2012 to October 2013, for IBS-like symptoms. At the time of the recruitment, the patients will be on GFD by at least one month and must be asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg and other foods) could be prescribed in patients who are suspected to suffer from multiple food hypersensitivity. The patients will be randomized to undergo a double-blind placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days. Before and after the challenge, the investigators will evaluate gastrointestinal (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood and fecal sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and rectoscopy, with multiple biopsies), for the identification of possible markers (serological, biochemical, immunological, histological features, expression of cytokines and other constitutive mucosal proteins from peripheral blood mononuclear cells, mucosal lymphocytes and fecal biomarkers) that may be of help to diagnose the condition of NCWS and to understand its pathogenesis.
Eligibility Criteria
Inclusion Criteria: * Adult patients, both genders, with age between 18-65 years, with IBS-like symptoms, that improved on a gluten free diet and worsen on a gluten containing diet * Patients testing negative for celiac disease ( anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific igE for wheat negative) Exclusion Criteria: * Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above); * Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat) * Subjects with Type 1 Diabetes * Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis) * Subjects with Helicobacter pylori infection and other gastrointestinal infection * Pregnancy
Contact & Investigator
Antonio Carroccio, PHD, MD
PRINCIPAL INVESTIGATOR
Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento) and University of Palermo, Palermo, Italy
Frequently Asked Questions
Who can join the NCT01762579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Not-celiac Wheat Sensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01762579 currently recruiting?
Yes, NCT01762579 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Palermo to inquire about joining.
Where is the NCT01762579 trial being conducted?
This trial is being conducted at Sciacca, Italy, Palermo, Italy.
Who is sponsoring the NCT01762579 clinical trial?
NCT01762579 is sponsored by University of Palermo. The principal investigator is Antonio Carroccio, PHD, MD at Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento) and University of Palermo, Palermo, Italy. The trial plans to enroll 100 participants.