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Osteoporosis In Non-Celiac Wheat Sensitivity Patients

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ClinicalTrials.gov Identifier: NCT02421783
Recruitment Status : Recruiting
First Posted : April 21, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pasquale Mansueto, University of Palermo

Brief 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 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.


Condition or disease
Non-celiac Wheat Sensitivity

Detailed Description:
Celiac disease (CD) has been reported to increase the risk of osteoporosis, with a resulting augmented risk of fractures. More recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. That previous study also showed a percentage of NCWS patients had weight loss and anemia: whether these depended on the intestinal malabsorption or not remains unclear. As yet no data are available on the presence and prevalence of low bone mass density (BMD) in NCWS patients. The aims of the present study is: 1) to investigate the prevalence of low BMD in NCWS patient and 2) to search for a possible correlation between BMD and other clinical characteristics, in particular the body mass index (BMI), of NCWS patients.

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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Osteoporosis In Non-Celiac Wheat Sensitivity Patients
Actual Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Osteoporosis

Group/Cohort
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.
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
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



Primary Outcome Measures :
  1. Change in bone mineral density (BMD) [ Time Frame: At baseline and at 24 months ]
    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.


Secondary Outcome Measures :
  1. Conventional lateral spine x-ray as an assessment of suspected osteoporotic vertebral fractures, using Genant's method [ Time Frame: At baseline ]
    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).

  2. Change in serum bone alkaline phosphatase [ Time Frame: At baseline and at 24 months ]
    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).

  3. Change in serum 25-hydroxyvitamin D [ Time Frame: At baseline and at 24 months ]
    Serum 25-hydroxyvitamin D values will be detected (refences values 30.0-74.0 ng/mL).

  4. Change in serum phosphorus levels [ Time Frame: At baseline and at 24 months ]
    Serum phosphorus levels values will be detected (refences values of subjects > or =18 years: 2.5-4.5 mg/dL).

  5. Change in serum calcium levels [ Time Frame: At baseline and at 24 months ]
    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)

  6. Change in urinary phosphorus levels [ Time Frame: At baseline and at 24 months ]
    Urinary phosphorus levels values will be detected (refences values 0.4-1.3 g per 24-hour urine sample).

  7. Change in urinary calcium levels [ Time Frame: At baseline and at 24 months ]
    Urinary calcium levels values will be detected (refences values 100-300 mg per 24-hour urine sample).

  8. Change in dietary intake and lifestyle [ Time Frame: At baseline and at 24 months ]
    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.


Biospecimen Retention:   Samples Without DNA
Biopsy specimens will be obtained from the bulb and the second duodenal portion


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include consecutive adult patients with irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS, referred at the Internal Medicine and at the Gastroenterology Units of the University Hospital of Palermo, between may 2015 and may 2017.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421783


Contacts
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Contact: Pasquale Mansueto, MD +39 0916554347 pasquale.mansueto@unipa.it

Locations
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Italy
Antonio Carroccio Recruiting
Sciacca, Agrigento, Italy
Pasquale Mansueto Recruiting
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Investigators
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Study Director: Antonio Carroccio, PhD Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy

Publications of Results:

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Responsible Party: Pasquale Mansueto, MD, University of Palermo
ClinicalTrials.gov Identifier: NCT02421783     History of Changes
Other Study ID Numbers: ACPM07
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by Pasquale Mansueto, University of Palermo:
Non-celiac wheat sensitivity
Multiple food allergy
Body mass index
Osteoporosis

Additional relevant MeSH terms:
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Osteoporosis
Hypersensitivity
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases