Gluten Challenge for Celiac Disease

Recruiting at 2 trial locations

Overseen By Kristi Kearney, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Antibiotics, PPIs, NSAIDs, others

Disqualifiers: Severe celiac, GI disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how celiac disease affects the body and interacts with gluten, genetics, gut bacteria, and the immune system. Participants in the "gluten challenge group" will consume a gluten-containing snack bar to assess its impact on symptoms and gut health. The trial includes three groups: individuals with diagnosed celiac disease on a gluten-free diet, those with suspected symptoms not on such a diet, and a control group without celiac issues. It is ideal for individuals diagnosed with celiac disease for at least a year who strictly follow a gluten-free diet. As an unphased trial, this study offers a unique opportunity to contribute to foundational research that could enhance the understanding and management of celiac disease.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but if you are in the control group, you cannot take antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs.

What prior data suggests that this gluten challenge is safe for individuals with celiac disease?

Research has shown that gluten can be problematic for people with celiac disease. One study found that some breakfast bars contain more gluten than is safe, with 12% of the samples tested having excessive gluten. This poses a risk of gluten exposure, particularly for those with celiac disease.

However, careful food preparation reduces the chance of gluten contamination in other foods. While this study tests a gluten snack bar to learn more about celiac disease, gluten remains unsafe for individuals with this condition. Consulting a doctor before joining such a study is crucial, as they can provide advice based on personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Gluten Challenge for Celiac Disease trial because it aims to explore how consuming gluten affects individuals with celiac disease. Most treatments for celiac disease involve a strict gluten-free diet, which can be challenging and limit lifestyle flexibility. This trial could provide deeper insights into the body's response to gluten reintroduction, potentially paving the way for new management strategies. By understanding these responses better, researchers hope to develop more nuanced guidelines or therapies that could improve quality of life for those with celiac disease.

What evidence suggests that this trial's treatments could be effective for celiac disease?

Research shows that eating gluten can cause harmful reactions in people with celiac disease. Gluten triggers the immune system to mistakenly attack the small intestine, causing damage. In this trial, participants in the gluten challenge group will consume a gluten-containing snack bar to trigger this response. This allows researchers to study how these reactions occur and their severity. Although eating gluten can worsen symptoms, it helps researchers understand the causes of symptoms and explore new treatments. ^{1 5 6 7 8}

Who Is on the Research Team?

Bana Jabri, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Adults aged 18-70 with celiac disease can join this trial. Participants must have been diagnosed by biopsy at least a year ago and followed a strict gluten-free diet for the past year. Pregnant women, those with chronic GI diseases, uncontrolled blood disorders, or severe reactions to gluten are excluded.

Inclusion Criteria

I was diagnosed with Celiac disease over a year ago through a biopsy.

I am 18-70, diagnosed with Celiac via biopsy over a year ago, and have been strictly gluten-free for the last 12 months.

I am 18-70, have celiac symptoms, and am not on a gluten-free diet.

Exclusion Criteria

I do not have severe celiac complications, other chronic GI diseases, IgA deficiency, severe gluten reactions, significant diseases, substance or alcohol abuse issues, pregnancy or lactation, or blood clotting disorders.

I do not have a history of chronic GI diseases, uncontrolled blood disorders, significant diseases, or substance abuse.

I am taking certain medications like antibiotics or aspirin, have had gastrointestinal surgery, or have a family history of celiac disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Gluten Challenge

Participants with diagnosed celiac disease undergo a gluten challenge to assess intestinal responses

6 weeks

Gluten De-challenge

Participants suspected of celiac disease are monitored while maintaining a gluten-free diet

12 months

Follow-up

Participants are monitored for safety and effectiveness after the gluten challenge and de-challenge phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gluten containing snack bar

Trial Overview The study is testing how eating a gluten-containing snack bar affects people with celiac disease. It looks at tissue damage and healing by examining interactions between gut cells, microbes, immune responses, genetics, and gluten.

How Is the Trial Designed?

Group I: Gluten challenge group Experimental Treatment 1 Intervention

Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months

Group II: Gluten de-challenge group Active Control 1 Intervention

Suspected celiac disease either showing typical symptoms or positive celiac disease serology

Group III: Control group Active Control 1 Intervention

No history or symptoms of celiac disease

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

California Institute of Technology

Collaborator

Trials

17

Recruited

4,300+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Celiac disease (CD) is triggered by gluten proteins in sensitive individuals, leading to damage in the small intestine, but there are promising alternatives for gluten-free products using non-gluten cereals and various gluten replacers.

Recent advances in gluten-free formulations include the use of pseudo cereals like amaranth and quinoa, as well as genetic modifications to wheat to reduce gluten content, indicating a growing market for gluten-free foods that meet the increasing demand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten-Free Products for Celiac Susceptible People. Rai, S., Kaur, A., Chopra, CS.[2020]

A new gluten-free diet evaluation software has been developed, containing over 700 gluten-free food items and their nutritional compositions, which helps dietitians assess the dietary intake of individuals with celiac disease more accurately.

This free software not only aids in diet evaluation and design but also serves as a nutritional education tool, promoting balanced self-care and improving the quality of life for people with celiac disease and gluten sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Software for Gluten-Free Diet Evaluation and Nutritional Education. Lasa, A., Larretxi, I., Simón, E., et al.[2020]

Out of 78 gluten-free food samples tested in the U.S., 61.5% contained gluten levels below the limit of quantification (10 mg/kg), indicating many products are safe for celiac patients.

However, 20.5% of the samples had gluten levels of 20 mg/kg or higher, with some breakfast cereals exceeding this limit, which poses a risk for individuals with gluten sensitivities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten contamination in foods labeled as "gluten free" in the United States. Lee, HJ., Anderson, Z., Ryu, D.[2023]

Gluten-free (GF) products marketed for children generally have lower levels of sodium, total fat, and saturated fat, but they also contain less protein and similar amounts of sugar compared to non-GF products.

Both GF and regular child-targeted products are classified as having poor nutritional quality, with a significant percentage of both types containing high levels of sugar, indicating that GF products are not necessarily healthier options for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nutritional Quality of Gluten-Free Products for Children. Elliott, C.[2022]

A study analyzing 3141 gluten-free food products from 1998 to 2016 found that gluten content has generally decreased, particularly in certified gluten-free (GF-L) products, improving safety for individuals with Celiac disease.

Despite overall improvements, some flour samples showed increased gluten levels above 100 mg/kg in recent years, indicating the need for continued monitoring and regulation of gluten content in food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of Gluten Content in Cereal-Based Gluten-Free Products: An Overview from 1998 to 2016. Bustamante, MÁ., Fernández-Gil, MP., Churruca, I., et al.[2018]

Patients with celiac disease must strictly avoid five cereals: wheat, rye, triticale, barley, and oats, as well as malt and hydrolyzed vegetable protein for very sensitive individuals.

Most other foods, including corn, rice, buckwheat, millet, and sorghum, are safe, and with careful label reading, patients can eat away from home without significant concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foods for patients with celiac disease. Campbell, JA.[2018]

A gluten-free snack made from brown rice, amaranth, and cactus pear peel was developed, showing improved physical and sensory properties, especially with a 10% substitution of cactus pear peel powder, which enhanced crispness and overall liking.

The snacks had lower fat content and adequate levels of protein and fiber compared to commercial brands, making them a nutritious alternative for those seeking gluten-free options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten-Free Snacks Based on Brown Rice and Amaranth Flour with Incorporation of Cactus Pear Peel Powder: Physical, Nutritional, and Sensorial Properties. Miranda, DV., Rojas, ML., Pagador, S., et al.[2023]

A new LC-MS/MS method was developed to detect rye in food, which can provide more accurate results than traditional immunoassays that may misidentify gluten due to cross-reactivity.

The study found rye contamination in some products labeled as gluten-free, including a spelt flour and a breakfast cereal, highlighting the importance of rigorous testing to ensure safety for individuals with celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catcher of the Rye: Detection of Rye, a Gluten-Containing Grain, by LC-MS/MS. Pasquali, D., Blundell, M., Howitt, CA., et al.[2020]

A study of 70 children and adolescents with celiac disease showed that while their gluten-free breakfasts can be nutritionally balanced, they tend to have lower protein and higher saturated fat compared to their gluten-containing counterparts.

Participants with celiac disease consumed more sugars and processed foods for breakfast, indicating a need for better reformulation of gluten-free products and a focus on increasing fruit intake for improved nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Composition of Breakfast in Children and Adolescents with and without Celiac Disease in Spain-Role of Gluten-Free Commercial Products. Úbeda, N., González, MP., Achón, M., et al.[2023]

Citations

1. isrctn.com isrctn.com/ISRCTN79155276

ISRCTN79155276: A study to learn if ZED1227 can ... The gluten-containing snack bar may exacerbate the participants' symptoms in response to gluten, this cannot be avoided as the study drug's effect on these ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8308338/

Food Safety and Cross-Contamination of Gluten-Free ... The consumption of gluten proteins drives adverse reactions in predisposed individuals who suffer from celiac disease (CD), wheat allergies, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772753X25001157

Development of gluten-free functional snack bar for ... This study focuses on developing a functional snack bar incorporating nutrient-dense ingredients such as quinoa, amaranth, dates, raisins, dried figs, ...

4. mdpi.com mdpi.com/1660-4601/21/2/124

Celiac Disease: Risks of Cross-Contamination and ... Celiac disease (CD) is the chronic immune-mediated enteropathy of the small bowel, manifesting when exposure to gluten occurs in genetically ...

5. researchgate.net researchgate.net/publication/358817597_Production_of_Gluten_Free_Functional_Bar_and_Examine_of_Some_Quality_Attributes

Production of Gluten Free Functional Bar and Examine ... Conclusion: Produced product; it is a healthy product for individuals with celiac, with its feature of meeting 30% of the daily fiber, 6% of both calcium and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0362028X25002078

Unmasking Hidden Gluten: Evaluating the Compliance of ... Our study aims to determine gluten levels in gluten-free products marketed in Lebanon and to assess the consumption frequency of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11055037/

Risk of Gluten Cross-Contamination Due to Food Handling ... The results indicate that shared environments and equipment may not significantly increase gluten cross-contamination if appropriate protocols are followed.

8. academic.oup.com academic.oup.com/nutritionreviews/advance-article/doi/10.1093/nutrit/nuaf069/8152198?searchresult=1

Gluten-Free Diet in the Context of Food and Nutrition Security ... A gluten-free diet (GFD) is the only safe treatment for people with gluten-related disorders (GRDs). However, adherence to a GFD is ...