Understanding tissue damage and healing in 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

This clinical study aims to investigate the biological mechanisms behind celiac disease, focusing on how factors like genetics, microbiota, and gluten affect tissue damage and healing. Participants will be divided into groups based on their gluten consumption: those on a gluten-free diet and those experiencing symptoms without dietary restrictions. The study will collect data on clinical symptoms and tissue health to improve patient care and understanding of the disease. By examining these interactions, researchers hope to fill gaps in knowledge regarding the variability in disease presentation and recovery among individuals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Gluten challenge group:

1. Age 18 to 75 years old
2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
3. Follow a strict gluten-free diet for at least the 12 consecutive months

Gluten de-challenge group:

1. Age 18 to 75 years old
2. Showing typical celiac disease symptoms
3. Not on a gluten-free diet

Control group:

1. Age 18 to 75 years old
2. Females who are not pregnant

Exclusion Criteria:

Gluten challenge group:

1. Diagnosis of any severe complication of celiac disease
2. Diagnosis of other chronic, active GI disease
3. Selective IgA deficiency
4. Severe reaction to gluten exposure
5. Any clinically significant diseases
6. History of significant substance or alcohol abuse
7. Pregnant or lactating
8. Diagnosis of blood clotting disorders

Gluten de-challenge group:

1. History of chronic inflammatory gastrointestinal disease
2. Gastrointestinal illness within the 4-week period prior to screening
3. History of lymphoproliferative disease
4. Uncontrolled blood clotting disorders
5. Any clinically significant diseases
6. History of significant substance or alcohol abuse

Control group:

1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
2. Known intestinal inflammation
3. Prior gastrointestinal surgery
4. Taking of antiplatelet agents or anticoagulants
5. Family history of celiac disease

Where it's running

• The University of Chicago
  Chicago, Illinois, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• California Institute of Technology
  Pasadena, California, United States Not yet recruiting

Study contacts

• Principal investigator: Bana Jabri, MD — University of Chicago
• Study coordinator: Sonia Kupfer, MD
• Email: skupfer@bsd.uchicago.edu
• Phone: (773) 834-1438

Similar studies

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

• 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

• Exercise for Metabolic Syndrome and Fatty Liver in Adolescent Girls with Celiac Disease

  This study tests whether a 3-month walking program helps improve metabolic syndrome and fatty liver in adolescent females with celiac disease.

  Recruiting Cairo University · Giza, Dokki · NCT07832994

• Nutrition and physical activity education for children with celiac disease

  This study tests whether a combined nutrition and physical activity education program helps 8- to 12-year-olds with celiac disease improve body health, eating habits, activity, and quality of life while on a gluten-free diet.

  Recruiting Bahçeşehir University · Istanbul, Besiktas · NCT07750795

• 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

• Omega-3 fats to reduce inflammation in adults with newly diagnosed celiac disease

  This study tests whether adding omega-3 fatty acid supplements to a gluten-free plan helps reduce inflammation and promote intestinal healing in adults who have just been diagnosed with celiac disease.

  Recruiting University of Chile · Santiago, Metropolitan Region · NCT07585669

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

  This project will test whether adults related to celiac patients have higher rates of non-celiac wheat sensitivity or IBS/functional dyspepsia and whether symptoms change on a wheat-free diet.

  Recruiting at 2 sites University of Palermo · Palermo, PA and 1 other locations · NCT07584473

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.