- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421783
Osteoporosis In Non-Celiac Wheat Sensitivity Patients
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 low BMD 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 BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Palermo, Italy, 90127
- Pasquale Mansueto
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Agrigento
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Sciacca, Agrigento, Italy
- Antonio Carroccio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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NCWS patients
Consecutive adult patients with an irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS.
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CD patients
Sex- and age-matched subjects with CD, diagnosed according to standard criteria during the same study period and enrolled as first control group
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IBS patients
Sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled as second control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in bone mineral density (BMD)
Time Frame: At baseline and at 24 months
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BMD will be assessed by dual x-ray absorptiometry (DXA), using a QDR Discovery Hologic DXA scanner in the femoral neck and in the lumbar spine.
For each scan, BMD and T-scores will be recorded.
A T-score between +1 and -1 is considered normal, between -1 and -2.5 indicates osteopenia, -2.5 or lower indicates osteoporosis.
The investigators also will calculate the 10-year fracture risks according to the standardized WHO FRAX equation, computed with BMD (T-score) at the femoral neck.
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At baseline and at 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Conventional lateral spine x-ray as an assessment of suspected osteoporotic vertebral fractures, using Genant's method
Time Frame: At baseline
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A random sample of the patients and controls will undergo conventional lateral spine x-ray for better assessment of suspected osteoporotic vertebral fractures, according to Genant's method (grade 0, no reduction; grade 1, minimal fracture, 20-25% vertebral height decrease; grade 2, moderate fracture, 25-40% vertebral height decrease; and grade 3, severe fracture, greater than 40% vertebral height decrease).
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At baseline
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Change in serum bone alkaline phosphatase
Time Frame: At baseline and at 24 months
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Serum bone alkaline phosphatase values will be detected (refences values of adults males < or =20 mcg/L; of adults premenopausal females < or =14 mcg/L; of adults postmenopausal females < or =22 mcg/L).
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At baseline and at 24 months
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Change in serum 25-hydroxyvitamin D
Time Frame: At baseline and at 24 months
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Serum 25-hydroxyvitamin D values will be detected (refences values 30.0-74.0 ng/mL).
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At baseline and at 24 months
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Change in serum phosphorus levels
Time Frame: At baseline and at 24 months
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Serum phosphorus levels values will be detected (refences values of subjects > or =18 years: 2.5-4.5 mg/dL).
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At baseline and at 24 months
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Change in serum calcium levels
Time Frame: At baseline and at 24 months
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Serum calcium levels values will be detected (refences values of males age 18-21 years: 9.3-10.3
mg/dL, age 22 years and older: 8.9-10.1 mg/dL; of females age 18 years and older: 8.9-10.1 mg/dL)
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At baseline and at 24 months
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Change in urinary phosphorus levels
Time Frame: At baseline and at 24 months
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Urinary phosphorus levels values will be detected (refences values 0.4-1.3
g per 24-hour urine sample).
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At baseline and at 24 months
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Change in urinary calcium levels
Time Frame: At baseline and at 24 months
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Urinary calcium levels values will be detected (refences values 100-300 mg per 24-hour urine sample).
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At baseline and at 24 months
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Change in dietary intake and lifestyle
Time Frame: At baseline and at 24 months
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All the participants will fill in a health and lifestyle questionnaire, considering menarche and age at menopause (if applicable), medical and drug abuse history, lifestyle habits (including elimination diet, smoking status, alcohol consumption, Italian espresso coffee drinking and physical activity); history of bone fractures will also be recorded.
In order to assess daily caloric intake and calcium intake, the subjects will receive a dietary form containing a printed list of the most common foods.
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At baseline and at 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Antonio Carroccio, PhD, Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy
Publications and helpful links
General Publications
- Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.
- Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
- Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.
- Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.
- Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.
- Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
- Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.
- Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndrome (IBS)-like patients. Clin Chem Lab Med. 2013 Jun;51(6):1257-63. doi: 10.1515/cclm-2012-0609.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACPM07
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