Osteoporosis In Non-Celiac Wheat Sensitivity Patients

Non-celiac Wheat Sensitivity Clinical Trial

Official title:

Osteoporosis In Non-Celiac Wheat Sensitivity Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421783
• Other study ID #: ACPM07
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2019
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: June 1, 2019
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Non-celiac Wheat Sensitivity
• Osteoporosis

Locations

Country	Name	City	State
Italy	Pasquale Mansueto	Palermo
Italy	Antonio Carroccio	Sciacca	Agrigento

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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 syndro — View Citation

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. — View Citation

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. Review. — View Citation

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. A — View Citation

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. — View Citation

Carroccio A, Soresi M, D'Alcamo A, Sciumè 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral density (BMD)	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.	At baseline and at 24 months
Secondary	Conventional lateral spine x-ray as an assessment of suspected osteoporotic vertebral fractures, using Genant's method	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).	At baseline
Secondary	Change in serum bone alkaline phosphatase	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).	At baseline and at 24 months
Secondary	Change in serum 25-hydroxyvitamin D	Serum 25-hydroxyvitamin D values will be detected (refences values 30.0-74.0 ng/mL).	At baseline and at 24 months
Secondary	Change in serum phosphorus levels	Serum phosphorus levels values will be detected (refences values of subjects > or =18 years: 2.5-4.5 mg/dL).	At baseline and at 24 months
Secondary	Change in serum calcium levels	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)	At baseline and at 24 months
Secondary	Change in urinary phosphorus levels	Urinary phosphorus levels values will be detected (refences values 0.4-1.3 g per 24-hour urine sample).	At baseline and at 24 months
Secondary	Change in urinary calcium levels	Urinary calcium levels values will be detected (refences values 100-300 mg per 24-hour urine sample).	At baseline and at 24 months
Secondary	Change in dietary intake and lifestyle	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.	At baseline and at 24 months