Wheat sensitivity or IBS/functional dyspepsia in relatives of people with celiac disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will recruit adult relatives of celiac disease patients who report IBS/FD-like or extraintestinal symptoms and screen them for non-celiac wheat sensitivity and IBS/FD. The work combines clinical evaluation with laboratory testing (including HLA DQ2/DQ8 status, intestinal permeability, and immunologic markers), gut microbiota analysis, and duodenal biopsy when indicated. Participants will be placed on a wheat-free diet and may undergo controlled wheat reintroduction for diagnostic purposes. Study outcomes include prevalence estimates, clinical and immunological profiles, changes in intestinal permeability and microbiota, and symptom response to dietary removal of wheat.

Why it matters

Who can join: the full rules

Inclusion criteria

* CD patient's relatives
* \>18 years old
* reporting IBS/FD-like and extraintestinal (EI) symptoms

Exclusion criteria

* self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes;
* drug and/or alcohol (\>30 g/day for men and \>20 g/day for women) abuse;
* treatment with steroids and/or non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;
* pregnancy or breastfeeding;
* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.

Where it's running

• Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo
  Palermo, PA, Italy Recruiting
• Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo
  Palermo, PA, Italy Recruiting

Study contacts

• Study coordinator: Pasquale Mansueto, MD
• Email: pasquale.mansueto@unipa.it
• Phone: +393477279879

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Low-FODMAP Diet vs Standard Dietary Advice for Functional Dyspepsia

  This study tests whether a low-FODMAP diet helps adults with functional dyspepsia compared with standard dietary advice.

  Recruiting King Chulalongkorn Memorial Hospital · Bangkok, Pathumwan · NCT07925073

• IBS and rosacea in adults: how common is rosacea among people with IBS at a university center

  This observational study tests how often rosacea occurs in adults with IBS who are treated at a university hospital in Bologna.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Italy · NCT07922668

• Probiotic in IBS-D and functional diarrhea (three-month test)

  A probiotic capsule is being tested to see if it can improve symptoms and quality of life for adults with diarrhea-predominant IBS or functional diarrhea compared with a placebo.

  Recruiting Szeged University · Szeged · NCT07916688

• Mediterranean diet and processed food in adults with celiac disease on a gluten-free diet

  This observational study looks at whether following a Mediterranean-style diet or eating more highly processed foods affects GI symptoms and quality of life in adults with celiac disease who have been on a strict gluten-free diet.

  Recruiting at 7 sites Istituti Clinici Scientifici Maugeri SpA · Brescia, BS and 6 other locations · NCT07915063

• Pain Reprocessing Therapy for Functional Dyspepsia

  A small pilot test to see if a psychological therapy that uses exposure techniques can lessen digestive symptoms and help daily functioning in people with functional dyspepsia.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07838324

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.