What side effects are associated with this type of intervention?

Common treatments for Celiac Disease primarily involve a strict gluten-free diet, which generally has no direct side effects but can be challenging to maintain and may lead to nutritional deficiencies if not properly managed. Immune response modulation treatments, such as those involving gluten powder, are still under investigation. Potential side effects of these treatments could include gastrointestinal symptoms, immune reactions, and possible exacerbation of Celiac Disease symptoms. Further research is needed to fully understand the safety and efficacy of these immune-modulating therapies.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Celiac Disease. The primary treatment remains a strict gluten-free diet. Research is ongoing in the area of immune response modulation, such as the study involving gluten powder, but these treatments are still in the trial phase and have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to gluten powder for immune response modulation in celiac disease patients include glutenases, AMG 714, BL 7010, IgY antibodies, 5 amino-salicylates, budesonide, nucleoside analogues, and newer biologics developed for other inflammatory diseases.

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Gluten Challenge for Celiac Disease

Q: What is the mechanism of action of this treatment?

The primary treatment for Celiac Disease is a strict gluten-free diet, which prevents the immune response that damages the small intestine. Emerging treatments, such as immune response modulation studied in trials with gluten powder, aim to desensitize the immune system to gluten. This could allow patients to tolerate small amounts of gluten without adverse effects, improving their quality of life by reducing dietary restrictions and preventing damage from accidental gluten exposure.

N/A

Recruiting

Led By Jocelyn A Silvester, MD, PhD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

History of more than minimal symptoms following gluten exposure on a gluten-free diet

Type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 hours

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this involves consuming gluten, participants especially those with celiac disease may experience digestive discomfort, such as bloating, gas, diarrhea or constipation; skin rashes; headaches; fatigue; and possibly pain.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have Type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment1 Intervention

Individuals without a diagnosis of celiac disease

Group II: Celiac DiseaseExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gluten Powder

2020

N/A

~30

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Celiac Disease is a strict gluten-free diet, which prevents the immune response that damages the small intestine. Emerging treatments, such as immune response modulation studied in trials with gluten powder, aim to desensitize the immune system to gluten. This could allow patients to tolerate small amounts of gluten without adverse effects, improving their quality of life by reducing dietary restrictions and preventing damage from accidental gluten exposure.

Properties of Gluten Intolerance: Gluten Structure, Evolution, Pathogenicity and Detoxification Capabilities.