- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421796
Malnutrition In Non-Celiac Wheat Sensitivity Patients
August 30, 2019 updated by: Pasquale Mansueto, University of Palermo
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Celiac disease (CD) has been reported to increase the risk of malnutrition due to malabsorption.
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 malnutrition in NCWS patient and 2) to search for a possible correlation with other clinical characteristics, in particular the body mass index (BMI), of NCWS patients.
Study Type
Observational
Enrollment (Actual)
270
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
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 |
---|---|---|
Change in body mass index (BMI)
Time Frame: At baseline and at 24 months
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The BMI [weight (kg) to the square of the height (m2)].
According to the World Health Organization, patients will be categorized as underweight (BMI <18.5), normal BMI 18.5 to 24.9, overweight BMI 25 to 29.9 and obese 30 to 39.9, and extreme obesity >40.
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At baseline and at 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in triceps skinfold thicknesses
Time Frame: At baseline and at 24 months
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Triceps skinfold measurement, using tricipital skinfold together with arm circumference, will be recorded as index of lean mass.
The investigators will use the standard formula: AMC (Arm Muscle Circumference, mm) = UAC (Upper Arm Circumference, mm) - π (3.14) x TSF (Triceps Skinfold, mm).
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At baseline and at 24 months
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Change in biometric impedance
Time Frame: At baseline and at 24 months
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Biometric impedance analysis will be performed to estimate total body water, extracellular water, fat-free mass and body cell mass.
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At baseline and at 24 months
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Change in serum albumin
Time Frame: At baseline and at 24 months
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Serum albumin levels will be assayed (references values 3.4-5.4
g/dL).
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At baseline and at 24 months
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Change in serum transferrin
Time Frame: At baseline and at 24 months
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Serum transferrin levels will be assayed (references values 200-360 mg/dL).
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At baseline and at 24 months
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Change in total serum cholesterol
Time Frame: At baseline and at 24 months
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Total serum cholesterol levels will be assayed (references values <200 mg/dL).
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At baseline and at 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Antonio Carroccio, PhD, Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
April 8, 2015
First Submitted That Met QC Criteria
April 20, 2015
First Posted (Estimate)
April 21, 2015
Study Record Updates
Last Update Posted (Actual)
September 3, 2019
Last Update Submitted That Met QC Criteria
August 30, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACPM08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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