- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03027492
Gynaecological Disorders in Not-celiac Wheat Sensitivity
Gynaecological Disorders in Patients With Not-celiac Wheat Sensitivity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Palermo, Italy, 90129
- Department of Internal Medicine, University Hospital of Palermo
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Agrigento
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Sciacca, Agrigento, Italy, 92019
- Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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.
To diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:
- positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
- presence of intestinal villous atrophy.
To diagnose IBS the standard Rome II (for retrospective patients) and Rome III (for prospective patients) Criteria will be adopted. None of these subjects improved on an elimination diet without wheat, cow's milk, egg, tomato, or chocolate.
Exclusion Criteria:
For NCWS diagnosis it will be evaluated the following 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 previously diagnosed gastrointestinal disorders
- other previously diagnosed gynaecological disorders
- nervous system disease and/or major psychiatric disorder
- physical impairment limiting physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1. NCWS retrospective patients
The clinical charts of NCWS female patients attending the outpatient centers of the Department of Internal Medicine at the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca will be reviewed with a retrospective method.
They had all been diagnosed with NCWS between January 2001 and June 2011 and included in a previously published study.
These charts included specific sections for associated gynaecological disorders.
Incomplete clinical charts will be excluded.
All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
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The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
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Active Comparator: 2. CD retrospective control patients
To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of CD female patients had been randomly chosen by a computer-generated method from female patients diagnosed during the same period (2001-2011) and age- (+2 years) matched with the NCWS female patients.
Similar to NCWS patients, also this control group was asked for gynaecological disorders and the answers reported in the patients clinical charts.
All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
|
The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
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Active Comparator: 3. IBS retrospective control patients
To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of IBS female patients had been randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2001-2011) and age- (+2 years) matched with the NCWS female patients.
Similar to NCWS patients, also this control group was asked for gynaecological disorders and the answers reported in the patients clinical charts.
All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
|
The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
|
Active Comparator: 4. NCWS prospective patients
The investigators prospectively will survey adult female patients with functional gastroenterological symptoms according to the Rome III criteria, and a suspected diagnosis of NCWS.
The patients will be recruited between January 2017 and January 2018 at the same 2 centers.
Most of the patients will be referred owing to gastrointestinal and extraintestinal symptoms, the onset of which, they reported, could be related to wheat ingestion.
In addition, patients will be asked about the presence and characteristics of gynaecological disorders using an ad hoc questionnaire.
All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
|
The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
|
Active Comparator: 5. CD prospective control patients
To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of CD female patients will be randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2017-2018) and age- (+2 years) matched with the NCWS female patients.
Similar to NCWS patients, also this control group will be asked for gynaecological disorders and the answers reported in the patients clinical charts.
All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
|
The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
|
Active Comparator: 6. IBS prospective control patients
To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of IBS female patients will be randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2017-2018) and age- (+2 years) matched with the NCWS female patients.
Similar to NCWS patients, also this control group will be asked for gynaecological disorders and the answers reported in the patients clinical charts.
All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
|
The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gynaecological disorders in NCWS female patients at baseline
Time Frame: Up to 200 months
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Prevalence of gynaecological disorders in retrospective and prospective NCWS female patients, compared to retrospective and prospective CD and IBS female patients.
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Up to 200 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gynaecological disorders in NCWS female patients after gluten-free diet.
Time Frame: Change from baseline at 6 months of gluten-free diet
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Gynaecological disorders evaluation after at least 6 months of gluten-free diet after the NCWS diagnosis, by visual analogic scales, specific questionnaire, and clinical examination, both in retrospective and prospective NCWS female patients.
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Change from baseline at 6 months of gluten-free diet
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Pap smear in NCWS female patients after gluten-free diet.
Time Frame: Change from baseline at 6 months of gluten-free diet
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PAP smear after at least 6 months of gluten-free diet after the NCWS diagnosis, both in retrospective and prospective NCWS female patients.
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Change from baseline at 6 months of gluten-free diet
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Collaborators and Investigators
Sponsor
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.
- 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.
- Di Liberto D, Mansueto P, D'Alcamo A, Lo Pizzo M, Lo Presti E, Geraci G, Fayer F, Guggino G, Iacono G, Dieli F, Carroccio A. Predominance of Type 1 Innate Lymphoid Cells in the Rectal Mucosa of Patients With Non-Celiac Wheat Sensitivity: Reversal After a Wheat-Free Diet. Clin Transl Gastroenterol. 2016 Jul 7;7(7):e178. doi: 10.1038/ctg.2016.35.
- Mansueto P, D'Alcamo A, Seidita A, Carroccio A. Food allergy in irritable bowel syndrome: The case of non-celiac wheat sensitivity. World J Gastroenterol. 2015 Jun 21;21(23):7089-109. doi: 10.3748/wjg.v21.i23.7089.
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
- ACPM15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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