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New treatment option for Non-celiac Wheat Sensitivity
Official title Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
ClinicalTrials.gov ID: NCT03024775
What this study is testing
- What it's testing
- Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sciacca, Agrigento, Italy
- Palermo, Palermo, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sciacca, Agrigento, Italy; Palermo, Palermo, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.