BridgeMD
New treatment option for Celiac Disease
Official title Tissue Destruction and Healing in Celiac Disease
ClinicalTrials.gov ID: NCT05680012
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Gluten challenge group:
- Age 18 to 75 years old
- Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
- Follow a strict gluten-free diet for at least the 12 consecutive months Gluten de-challenge group:
- Age 18 to 75 years old
You likely can't join if
- Gluten challenge group:
- Diagnosis of any severe complication of celiac disease
- Diagnosis of other chronic, active GI disease
- Selective IgA deficiency
- Severe reaction to gluten exposure
- Any clinically significant diseases
See the full eligibility criteria
- Gluten challenge group:
- Age 18 to 75 years old
- Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
- Follow a strict gluten-free diet for at least the 12 consecutive months Gluten de-challenge group:
- Age 18 to 75 years old
- Showing typical celiac disease symptoms
- Not on a gluten-free diet Control group:
- Age 18 to 75 years old
- Females who are not pregnant
- Gluten challenge group:
- Diagnosis of any severe complication of celiac disease
- Diagnosis of other chronic, active GI disease
- Selective IgA deficiency
- Severe reaction to gluten exposure
- Any clinically significant diseases
- History of significant substance or alcohol abuse
- Pregnant or lactating
- Diagnosis of blood clotting disorders Gluten de-challenge group:
- History of chronic inflammatory gastrointestinal disease
- Gastrointestinal illness within the 4-week period prior to screening
- History of lymphoproliferative disease
- Uncontrolled blood clotting disorders
- Any clinically significant diseases
- History of significant substance or alcohol abuse Control group:
- Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
- Known intestinal inflammation
- Prior gastrointestinal surgery
- Taking of antiplatelet agents or anticoagulants
- Family history of celiac disease
The study team makes the final eligibility decision.
Where it's taking place
- Pasadena, California, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pasadena, California, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.