Gluten Challenge for Celiac Disease

Recruiting at 1 trial location

Overseen By Marisa Stahl, MD, MSCS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Pregnancy, Wheat allergy, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial involves people with celiac disease and healthy individuals eating gluten powder to study their immune responses by measuring inflammation-related proteins in their blood.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is the gluten challenge safe for people with celiac disease?

Research indicates that certain ancient wheat like Triticum monococcum may be safe for people with celiac disease, but gluten from common sources like wheat, barley, and rye can trigger immune reactions in these individuals. ^{1 2 3 4 5}

How does the gluten challenge treatment for celiac disease differ from other treatments?

The gluten challenge treatment for celiac disease is unique because it involves intentionally consuming gluten to trigger symptoms, which helps in diagnosing the condition, unlike the standard gluten-free diet that avoids gluten to prevent symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Jocelyn A Silvester, MD, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for people who have been on a gluten-free diet for at least 4 weeks. It's specifically for those with celiac disease confirmed by tests and healthy individuals willing to eat gluten powder for the study. People with wheat allergies, severe underweight issues (BMI z-score < -2), Type 1 diabetes, or other conditions that could affect the study can't participate.

Inclusion Criteria

You are willing to eat gluten-containing foods as part of the study.

My celiac disease diagnosis was confirmed through blood tests or tissue samples.

You have been following a gluten-free diet for at least 4 weeks.

Exclusion Criteria

You are allergic to wheat.

I experience significant symptoms when I eat gluten, despite being on a gluten-free diet.

Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume a single oral dose of gluten powder and provide blood samples for cytokine measurement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immune response changes after gluten consumption

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Gluten Powder

Trial Overview The trial is testing how eating gluten powder affects immune responses in people with celiac disease compared to healthy controls. Participants will consume gluten after maintaining a strict gluten-free diet to see how their bodies react.

How Is the Trial Designed?

Group I: Healthy Controls Experimental Treatment 1 Intervention

Individuals without a diagnosis of celiac disease

Group II: Celiac Disease Experimental Treatment 1 Intervention

Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Celiac Disease Foundation

Collaborator

Trials

1

Recruited

400+

Published Research Related to This Trial

In a study involving 12 patients with coeliac disease, the ancient wheat Triticum monococcum (Tm) did not significantly alter intestinal permeability compared to rice and a toxic wheat protein, suggesting it may be safe for further investigation as an alternative to a gluten-free diet.

Adverse gastrointestinal events were mild or moderate for Tm and rice, while the toxic protein Amygluten caused more severe reactions, indicating that Tm is well tolerated and warrants additional research for its safety in coeliac disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease. Zanini, B., Petroboni, B., Not, T., et al.[2021]

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]

The updated GluPro database now includes a comprehensive collection of prolamin sequences from various cereals, which is crucial for developing accurate methods to detect gluten levels in foods for coeliac patients.

Analysis of these sequences revealed that certain minor proteins in wheat and barley lack the toxic motifs associated with coeliac disease, suggesting potential for safer gluten-free food options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping Coeliac Toxic Motifs in the Prolamin Seed Storage Proteins of Barley, Rye, and Oats Using a Curated Sequence Database. Daly, M., Bromilow, SN., Nitride, C., et al.[2020]

In a study analyzing 640 samples of naturally gluten-free ingredients sold in Canada, 9.5% were found to be contaminated with gluten above the safe limit of 20 mg/kg, indicating a significant risk for individuals with gluten sensitivities.

Higher fiber ingredients like soy, millet, and buckwheat showed the highest levels of gluten contamination, suggesting that these foods may pose a greater risk for gluten exposure, especially when not labeled as gluten-free.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten contamination of naturally gluten-free flours and starches used by Canadians with celiac disease. Koerner, TB., Cleroux, C., Poirier, C., et al.[2017]

The study successfully developed sensory appealing crackers that are both high in fiber and low in FODMAPs, making them suitable for patients with irritable bowel syndrome and non-celiac wheat sensitivity.

The best formulations, made from a mixture of maize and millet flour with added sourdough and seeds, received high acceptability ratings and can be marketed as gluten-free, low-FODMAP, high-fiber, and high-protein products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of High-Fibre and Low-FODMAP Crackers. Radoš, K., Čukelj Mustač, N., Varga, K., 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 study involving ten treated coeliac patients showed that consuming gliadin-containing gluten-free bread for 6 weeks did not significantly change jejunal biopsy results or 51Cr-EDTA excretion levels.

However, four patients experienced diarrhea, indicating that wheat starch-based gluten-free products can still cause symptoms in individuals with coeliac disease, highlighting the need for careful monitoring of gluten-free food ingredients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a gliadin-containing gluten-free product in coeliac patients. Ciclitira, PJ., Cerio, R., Ellis, HJ., et al.[2013]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Mapping Coeliac Toxic Motifs in the Prolamin Seed Storage Proteins of Barley, Rye, and Oats Using a Curated Sequence Database. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Gluten contamination of naturally gluten-free flours and starches used by Canadians with celiac disease. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Development of High-Fibre and Low-FODMAP Crackers. [2023]

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

Foods for patients with celiac disease. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a gliadin-containing gluten-free product in coeliac patients. [2013]