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 investigates the immune system's reaction when individuals with celiac disease consume gluten. Participants take gluten powder, and researchers observe immune responses in both those with celiac disease and healthy individuals without the condition. Individuals who have followed a gluten-free diet for at least four weeks and have a confirmed celiac diagnosis might be suitable if they are willing to consume gluten for the study. As an unphased trial, this study provides a unique opportunity to advance scientific understanding of celiac disease and gluten reactions.

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.

What prior data suggests that this gluten challenge is safe for participants?

Research has shown that gluten can cause problems for people with celiac disease. Gluten, a protein found in wheat, is safe for most people, but those with celiac disease may experience negative reactions. Experts indicate that up to 10 milligrams of gluten per day is usually safe for most individuals with celiac disease. However, even small amounts can cause symptoms like stomach pain and bloating in some cases.

For those without celiac disease, gluten is generally safe and does not cause harm. It is important to note that the study used gluten powder, which might cause different reactions depending on individual sensitivity. Always consult healthcare professionals if there are concerns about consuming gluten. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Gluten Powder trial for celiac disease because it aims to explore how a controlled gluten challenge impacts individuals with the condition. Unlike standard treatments that require lifelong adherence to a strict gluten-free diet, this approach involves reintroducing gluten in a monitored setting to better understand immune responses. This could help identify specific biomarkers or immune reactions, potentially leading to more personalized and effective management strategies for celiac disease. By comparing reactions between those with celiac disease and healthy controls, researchers hope to uncover new insights into the disease's mechanisms.

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

Research has shown that gluten can cause immune reactions in people with celiac disease. Their bodies mistakenly perceive gluten as harmful, leading to symptoms like stomach pain and bloating. Studies have found that even tiny amounts of gluten can trigger these reactions in those with celiac disease. This trial will compare participants with a confirmed diagnosis of celiac disease to healthy controls without the condition to study these immune reactions. For people without celiac disease, gluten usually doesn't cause such strong reactions. Therefore, researchers use gluten in studies to learn how the immune system reacts in people with and without celiac disease. ^{6 7 8 9 10}

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

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]

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]

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]

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]

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]

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]

Citations

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Long-term health outcomes of people without celiac ... Self-reported abdominal symptoms after consuming gluten-containing cereals in individuals without celiac disease (CeD) are common.

2. hcplive.com hcplive.com/view/1-in-10-people-celiac-disease-report-gluten-wheat-sensitivity

1 in 10 People Without Celiac Disease Report Gluten or ... Study finds non-celiac gluten or wheat sensitivity is more common in women and linked to IBS, anxiety, and depression.

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Study highlights high prevalence of non-coeliac gluten ... Symptoms of NCGWS tend to improve when gluten or wheat is avoided and recur when foods containing them are returned to the diet. However, in ...

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Gluten May Not Be the Gut Wrecker People Think. A New ... Of the 10 percent who claim to be gluten-intolerant, only 16 to 30 percent have symptoms specifically triggered by gluten, according to prior ...

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Gluten-free diet adherence patterns and health outcomes in ... The increases in VitD, HCT, MCH, and T3 levels suggest that sustained adherence to the GFD is effective in addressing key deficiencies often ...

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Label Reading & the FDA If a product claims to be gluten-free on the package, then it is most likely safe to eat as the FDA only allows packaged foods with less than 20 parts per ...

7. nutritionsource.hsph.harvard.edu nutritionsource.hsph.harvard.edu/gluten/

Gluten: A Benefit or Harm to the Body? - The Nutrition Source [1] In fact, the findings also suggested that non-celiac individuals who avoid gluten may increase their risk of heart disease, due to the potential for reduced ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8391170/

Wheat/Gluten-Related Disorders and Gluten-Free Diet ... This review aims to critically discuss the nutritional components of wheat, highlighting both the health benefits and wheat/gluten-related disorders.

9. fda.gov fda.gov/media/81500/download

Health Hazard Assessment for Gluten Exposure in ... The introductory hazard identification section examines and provides an overview of the nature and characteristics of the adverse effects associated.

10. gluteostop.com gluteostop.com/en/gluten-level-the-10mg-limit

GLUTEN LEVEL – The 10mg limit 10 milligrams of gluten per day is generally considered by many experts to be a safe amount for the majority of people with celiac disease.