Bio-markers of Not-celiac Wheat Sensitivity

NCT01762579 | Recruiting DMC

• 1 other identifier: ACPM03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the investigators' study is to evaluate biochemical, immunological and histological characteristics of patients affected with the so-called "gluten (or wheat) sensitivity" who suffers from irritable bowel syndrome (IBS)-like symptoms. As it is not known what component of the cereals causes the symptoms in so called "gluten-sensitive" patients, the investigators prefer to speak of "not-celiac wheat sensitivity" (NCWS). NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat consumption, that improved on wheat/gluten free diet (GFD). For our research, we will select adult patients, both genders, affected with suspected NCWS (i.e. with symptoms/signs which disappeared on GFD and worsen on a gluten containing diet, testing negative for celiac disease \[anti-tissue transglutaminase antibodies, anti-tTG, and anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1\] and wheat allergy \[serum specific IgE for wheat\]). The patients will be recruited at the Department of Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of the University of Palermo, from January 2012 to October 2013, for IBS-like symptoms. At the time of the recruitment, the patients will be on GFD by at least one month and must be asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg and other foods) could be prescribed in patients who are suspected to suffer from multiple food hypersensitivity. The patients will be randomized to undergo a double-blind placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days. Before and after the challenge, the investigators will evaluate gastrointestinal (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood and fecal sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and rectoscopy, with multiple biopsies), for the identification of possible markers (serological, biochemical, immunological, histological features, expression of cytokines and other constitutive mucosal proteins from peripheral blood mononuclear cells, mucosal lymphocytes and fecal biomarkers) that may be of help to diagnose the condition of NCWS and to understand its pathogenesis.

Conditions

Not-celiac Wheat Sensitivity

Keywords

Not-celiac wheat sensitivity; Gluten; esophagogastroduodenoscopy; Rectoscopy

Outcome Measures

Primary Outcomes (1)

• Symptoms/signs evaluation

  Symptoms/signs evaluation, before and after the challenge: total score before and after 2 weeks of wheat (or placebo) ingestion

  Change from baseline (i.e. before diagnosis of suspected NCWS, on free diet, and after diagnosis of suspected NCWS, on GFD) at 2 weeks

Secondary Outcomes (1)

• Bio-Markers evaluation

  Change from baseline (i.e. before diagnosis of suspected NCWS, on free diet, and after diagnosis of suspected NCWS, on GFD) at 2 weeks

Study Arms (2)

wheat flour

ACTIVE COMPARATOR

wheat flour is administered blindly versus placebo for 15 days

Dietary Supplement: wheat flour; Dietary Supplement: Xylose

Xylose

PLACEBO COMPARATOR

placebo will be administered blindly versus wheat flour for 15 days

Dietary Supplement: wheat flour; Dietary Supplement: Xylose

Interventions

wheat flour DIETARY_SUPPLEMENT

wheat flour is administered three times per day for 15 days

Xylose; wheat flour

Xylose DIETARY_SUPPLEMENT

Xylose will be administered three times per day for 15 days

Xylose; wheat flour

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, both genders, with age between 18-65 years, with IBS-like symptoms, that improved on a gluten free diet and worsen on a gluten containing diet
• Patients testing negative for celiac disease ( anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific igE for wheat negative)

You may not qualify if:

• Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above);
• Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat)
• Subjects with Type 1 Diabetes
• Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
• Subjects with Helicobacter pylori infection and other gastrointestinal infection
• Pregnancy

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (2)

Internal Medicine, "Giovanni Paolo II" Hospital

Sciacca, Agrigento, Italy

RECRUITING

Internal Medicine, University Hospital

Palermo, Palermo, 90100, Italy

RECRUITING

Related Publications (2)

• Seidita A, Giuliano A, Soresi M, Chiavetta M, Nardi E, Mogavero G, Giannone G, Carroccio A, Mansueto P. Fecal calprotectin levels in patients with non-celiac wheat sensitivity: a proof of concept. Intern Emerg Med. 2024 Aug;19(5):1255-1266. doi: 10.1007/s11739-024-03595-7. Epub 2024 Apr 12.

  PMID: 38609737 DERIVED

• Carroccio A, Giannone G, Mansueto P, Soresi M, La Blasca F, Fayer F, Iacobucci R, Porcasi R, Catalano T, Geraci G, Arini A, D'Alcamo A, Villanacci V, Florena AM. Duodenal and Rectal Mucosa Inflammation in Patients With Non-celiac Wheat Sensitivity. Clin Gastroenterol Hepatol. 2019 Mar;17(4):682-690.e3. doi: 10.1016/j.cgh.2018.08.043. Epub 2018 Aug 21.

  PMID: 30138736 DERIVED

MeSH Terms

Interventions

Flour; Xylose

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pentoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Antonio Carroccio, PHD, MD

  Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento) and University of Palermo, Palermo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 7, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2016
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)