Bioelectrical Impedance Analysis of Not-celiac Wheat Sensitivity Patients

NCT01762566 | Completed DMC

• 1 other identifier: ACPM02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Aim of the investigators' study is to evaluate one of the symptoms described by patients affected with the so-called "not-celiac wheat sensitivity" (NCWS). NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat consumption and improve on Gluten Free Diet (GFD). Among these, patients often report the appearance of bloating and abdominal pain, and, sometimes, swelling of fingers and face, shortly after ingestion of wheat. They also refer that swelling tends to last for some hours and then to disappear on GFD. To our knowledge, this disorder has never been investigated neither proved. For the investigators' research, the investigators selected adult patients, both genders, affected with NCWS. Diagnostic criteria include: 1) symptoms disappearance on GFD, 2) testing negative for celiac disease \[anti-tTG and EMA, and with biopsy Marsh 0-1\] and wheat allergy \[serum specific IgE for wheat\], 3) positive response to a double-blind placebo-controlled challenge (DBPC) with wheat or placebo. Patients will be recruited among subjects referring, as outpatients, to 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. The investigators will include patients referring for functional dyspepsia and/or irritable bowel syndrome (IBS)-like symptoms. All recruited patients must report body's swelling immediately after wheat ingestion. In all recruited patients, NCWS diagnosis was posed during the previous years, according to the above mentioned criteria. Patients, all on GFD for at least 30 days, will undergo to another DBPC with wheat or placebo (xylose), performed by administering capsules coded as A or B containing wheat or xylose, respectively. Capsules A or B will be administered once, and then, after 1 week of washout, patients received the other capsules, given once too. Before and 2 hours after every challenge, patients will undergo a complete medical examination (measurement of body weight, height, body mass index \[BMI\], waist circumference, diameter of thighs, legs, arms, and fingers), and we will perform bioelectrical impedance analysis and collect blood sampling, for identification of possible markers (bioelectrical, immunologic, hormonal, etc) that may help to demonstrate and explain mechanisms of examined symptom.

Conditions

Not-celiac Gluten (Wheat) Sensitivity

Keywords

Not-celiac gluten (wheat) sensitivity; Bioelectrical impedance analysis; Bloating; Swelling

Outcome Measures

Primary Outcomes (1)

• Symptom evaluation

  Symptom evaluation, before and after the challenge, by complete medical examination, with measurement of body weight, height, body mass index (BMI), waist circumference, diameter of thighs, legs, arms, and fingers

  Change from baseline and at 2 hours

Secondary Outcomes (1)

• Bio-Markers evaluation

  Change from baseline and at 2 hours

Study Arms (2)

wheat

ACTIVE COMPARATOR

wheat is administered blindly versus placebo in capsules once

Dietary Supplement: wheat; Dietary Supplement: xylose

xylose

PLACEBO COMPARATOR

placebo (xylose) will be administered blindly versus wheat in capsules once

Dietary Supplement: wheat; Dietary Supplement: xylose

Interventions

wheat DIETARY_SUPPLEMENT

wheat is administered blindly versus placebo in capsules once

wheat; xylose

xylose DIETARY_SUPPLEMENT

placebo (xylose) will be administered blindly versus wheat in a capsule once

wheat; xylose

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 gastrointestinal symptoms/signs that improved on a gluten-free diet and worsen on a wheat containing diet
• Patients testing negative for celiac disease (i.e. anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific IgE for wheat negative)
• gluten sensitivity diagnosis confirmed with a double-blind placebo-controlled challenge with gluten or placebo

You may not qualify if:

• Patients diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology - (presence of villi atrophy);
• Patients diagnosed with wheat allergy (positive serum specific IgE for wheat)
• Patients suffering from Diabetes Mellitus
• Patients with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
• Patients 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

Location

Internal Medicine, University Hospital of Palermo

Palermo, Palermo, 90100, Italy

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Flour; Xylose

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Antonio Carroccio, PHD

  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: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

IT (2)