CompletedNot Applicable

Malnutrition In Non-Celiac Wheat Sensitivity Patients

Italy270 participantsStarted 2015-05-01

Plain-language summary

Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of malnutrition in NCWS patients and search for correlations with other clinical characteristics. This prospective observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the Gastroenterology Units of the University of Palermo. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent nutritional parameters measurement, duodenal histology, Human Leucocyte Antigen (HLA) DQ typing and body mass index (BMI) evaluation.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria: * negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies; * absence of intestinal villous atrophy; * negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum specific IgE detection); * resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms; * symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the investigators previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges will be performed too. Additional inclusion criteria will be: * age \>18 years; follow-up duration longer than six months after the initial diagnosis; * at least two outpatient visits during the follow-up period. Exclusion Criteria: * positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa; * self-exclusion of wheat from the diet and refusal to reintroduce it, before entering the study; * other "organic" gastrointestinal disorders; * nervous system disease and/or major psychiatric disorder; * physical impairment limiting physical activity; * menopause; * steroid and sex steroid therapy, hormone replacement therapy or ovariectomy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in body mass index (BMI)

Timeframe: At baseline and at 24 months

Trial details

NCT IDNCT02421796

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-10-01

View on ClinicalTrials.gov More Non-Celiac Wheat Sensitivity trials