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

Trial Summary

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.

Is the gluten challenge safe for humans?

The research does not provide specific safety data for the gluten challenge, but it highlights that even small amounts of gluten can be harmful to people with celiac disease, suggesting caution is needed. ^{1 2 3 4 5}

How does the gluten-containing snack bar treatment for celiac disease differ from other treatments?

The gluten-containing snack bar treatment is unique because it involves intentionally consuming gluten to challenge the body's response, unlike the standard lifelong gluten-free diet which avoids gluten entirely to prevent symptoms. ^{1 6 7 8 9}

What is the purpose of this trial?

The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.

Research Team

Bana Jabri, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gluten contamination in foods labeled as "gluten free" in the United States. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Evolution of Gluten Content in Cereal-Based Gluten-Free Products: An Overview from 1998 to 2016. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

New Software for Gluten-Free Diet Evaluation and Nutritional Education. [2020]

5. Switzerland 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. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Foods for patients with celiac disease. [2018]

7. United States 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. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Gluten-Free Products for Celiac Susceptible People. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Catcher of the Rye: Detection of Rye, a Gluten-Containing Grain, by LC-MS/MS. [2020]