Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
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ClinicalTrials.gov Identifier: NCT03024775 |
Recruitment Status :
Recruiting
First Posted : January 19, 2017
Last Update Posted : May 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Non-celiac Wheat Sensitivity | Dietary Supplement: Wheat flour Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Clinical Response and Cytokines Production After Challenge With Different Wheat Genotypes in Patients With Not-celiac Wheat Sensitivity. |
Actual Study Start Date : | January 1, 2017 |
Estimated Primary Completion Date : | January 1, 2023 |
Estimated Study Completion Date : | June 1, 2023 |

Arm | Intervention/treatment |
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Active Comparator: Active Comparator 1
Wheat flour with high inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.
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Dietary Supplement: Wheat flour
Wheat flour will be administered three times per day for 15 days. |
Active Comparator: Active Comparator 2
Wheat flour with low inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.
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Dietary Supplement: Wheat flour
Wheat flour will be administered three times per day for 15 days. |
Placebo Comparator: Placebo 1
Placebo (xylose) will be administered blindly versus wheat flour with high inflammatory response for 15 days in NCWS patients.
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Dietary Supplement: Placebo
Placebo (xylose) will be administered three times per day for 15 days. |
Placebo Comparator: Placebo 2
Placebo (xylose) will be administered blindly versus wheat flour with low inflammatory response for 15 days in NCWS patients.
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Dietary Supplement: Placebo
Placebo (xylose) will be administered three times per day for 15 days. |
- Inflammatory response to wheat genotypes by PBMC of NCWS patients and healthy control subjects. [ Time Frame: Through study completion, an average of 6 months ]Cytokines evaluation in response to gluten and non-gluten proteins from total kernel proteins of different wheat genotypes (i.e. ancient vs. modern vs. genetically modified) by PBMC of patients with a definitive diagnosis of NCWS, at the end of the diagnostic Double-Blind Placebo-Controlled (DBPC) wheat challenge, and of healthy control subjects.
- Inflammatory response to wheat genotypes by rectal immunocytes of NCWS patients and healthy control subjects. [ Time Frame: Through study completion, an average of 6 months ]Rectal immunocytes evaluation in response to gluten and non-gluten proteins from total kernel proteins of different wheat genotypes (i.e. ancient vs. modern vs. genetically modified) by immunocytes extracted by the rectal mucosa of patients with a definitive diagnosis of NCWS, at the end of the diagnostic Double-Blind Placebo-Controlled (DBPC) wheat challenge, and of healthy control subjects.
- Clinical response to wheat genotypes in NCWS patients [ Time Frame: Change from baseline at 2 weeks ]Symptoms evaluation before and after a 2 weeks challenge with two wheat genotypes showing the highest and the lowest in vitro inflammatory response in diagnosed NCWS patients on gluten-free diet. During the challenge periods, the severity of symptoms will be recorded: the patients will complete a 100mm visual analog scale, which assesses the specific symptoms they report. The challenges will be considered positive if the same symptoms which had been initially present will reappear after their disappearance on elimination diet.

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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 |
Inclusion Criteria:
All the patients will meet the recently proposed criteria:
- negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
- absence of intestinal villous atrophy
- IgE-mediated immunoallergic tests negative to wheat (skin prick tests and/or serum specific IgE detection)
- follow-up duration >12 months after the initial diagnosis
- at least two outpatient visits during the follow-up period.
Adjunctive criteria adopted in our patients will be:
- resolution of the gastrointestinal symptoms on a standard elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms
- symptom reappearance on DBPC wheat challenge, performed as described previously. As in previous studies, DBPC cow's milk protein challenge and other "open" food challenges will be also performed.
Exclusion Criteria:
Exclusion criteria will be:
- age <18 years
- positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal
- self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study
- other organic gastrointestinal diseases (i.e. careful exclusion of Crohn's disease)
- concomitant treatment with steroids and/or antihistamines.

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): NCT03024775
Contact: Antonio Carroccio, PhD | +390916552884 | acarroccio@hotmail.com | |
Contact: Pasquale Mansueto, MD | +390916552884 | pasquale.mansueto@unipa.it |
Italy | |
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca | Recruiting |
Sciacca, Agrigento, Italy, 92019 | |
Contact: Antonio Carroccio, MD, PhD +390916554347 acarroccio@hotmail.com | |
Department of Internal Medicine, University Hospital of Palermo | Recruiting |
Palermo, Italy, 90129 | |
Contact: Pasquale Mansueto, MD +390916554347 pasquale.mansueto@unipa.it |
Study Director: | Antonio Carroccio, PhD | University of Palermo |
Other Publications:
Responsible Party: | Pasquale Mansueto, MD, University of Palermo |
ClinicalTrials.gov Identifier: | NCT03024775 |
Other Study ID Numbers: |
ACPM16 |
First Posted: | January 19, 2017 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Non-celiac Wheat Sensitivity ancient wheats modern wheats ATIs |
Hypersensitivity Immune System Diseases |