Celiac Disease (Gluten-Free Diet)

About Celiac Disease (Gluten-Free Diet) Clinical Trials (Click to Open)

Join Clinical Trials for Celiac Disease (Gluten-Free Diet)

Celiac Disease (Gluten Free Diet)

General Purpose:

Celiac disease is a disease of the small intestine that results from hypersensitivity to a specific protein known as gluten. Gluten is commonly found in foods made from barley, wheat, and rye, examples of which include bread, pasta, and cereals.

Gluten can also be incorporated as an ingredient in some medications, vitamins, and cosmetics. Individuals who have celiac disease essentially experience an internal allergic reaction within their small intestine each time they consume a food containing gluten, or use a medicine or product in which it is an ingredient.

This immune reaction is damaging to the lining of the small intestine and impairs the body’s ability to absorb nutrients from food.  

No one knows exactly what causes celiac disease, and it can develop at any point in time. Symptoms often vary between individuals which can make it difficult to diagnose. Common symptoms include abdominal pain, bloating, gas, indigestion, constipation, changes in appetite, diarrhea, lactose intolerance, nausea and vomiting, stool irregularities, and unexplained weight loss.

 Additional symptoms may arise over time as a result of nutritional deficiencies that can result from celiac disease. Celiac disease can generally be diagnosed by a special blood test and by examining a sample of intestinal tissue (obtained through a biopsy).

Celiac disease research has made great strides in recent years, with the development and testing of quicker and more accurate diagnostic tests, testing vaccines to prevent the development of celiac disease, and evaluating the effectiveness of current treatments, testing new and potentially useful drugs. Researchers are also working to gain a better understanding of how and why celiac disease develops, and how it responds to various treatments.

What Will Celiac Disease Clinical Trials Be Like?

The types of tests and assessments used in celiac disease clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be used and incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Blood tests may be performed to detect exceptionally high levels of certain antibodies (immune system cells that work to eliminate foreign substances). In celiac disease, the body develops antibodies that target gluten, which results in the hypersensitivity that characterizes the condition.
  • Biopsy
  • Endoscopy:  a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is fed down the mouth or nose, through the esophagus, and into the small intestine.
  • Some studies may require that patients swallow a small camera-containing pill that takes thousands of pictures while inside the body, and transmits them to a receiver worn on the patient’s belt. The pill is then excreted from the body in the stool.  
  • Upper GI series: a series of x-rays performed after an individual has fasted for a period of time and then consumed a chalky-tasting liquid that makes the stomach and intestines more visible on x-ray.
  • Dietary interventions, including the elimination of all gluten-containing foods.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Celiac Disease Clinical Trial Protocol:

Specific examples of clinical trials for celiac disease might include the following:

  • A randomized clinical trial in which a type of probiotic bacterial medication (similar to the active cultures found in yogurt) is studied to determine its impact on the symptoms and quality of life measures among women with celiac disease. In such a study, participants would be randomly assigned to receive treatment with either the probiotic medication or a placebo. After a month of therapy, they would be evaluated to determine their degree of symptom improvement, as well as complete a series of questionnaires designed to assess their quality of life.
  • A long-term study to determine if the early feeding patterns of infants – in particular the timing of introduction to gluten-containing foods – are associated with the development of celiac disease. In this study, half of the infants would be randomly assigned to have gluten introduced into their diet per standard recommendations of the American Academy of Pediatrics (i.e., at six months of age), while the remaining half of the infants would continue with a gluten-free diet until the age of 12 months, at which point they could resume an unrestricted diet. Infants would be evaluated every six months until the age of six to assess for the presence of celiac disease. Researchers would then compare the two groups to see if one had more incident cases of celiac disease develop than the other.
  • A study designed to evaluate the effectiveness of a vaccine designed to prevent the development of celiac disease.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as the first clinical trial example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of celiac disease (time since onset, age at diagnosis, your specific symptoms)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your current dietary habits (gluten-free, reduced gluten diet, etc.)

Suggested Search Terms: 

 “celiac disease prevention,” “celiac disease management,” “celiac disease treatment,” “celiac disease genetics,” “celiac disease diet,” “celiac disease children,” “celiac disease pediatric,” “celiac disease infants,” “celiac disease diagnosis,” “celiac disease nutrition,” “celiac disease vitamin,” “celiac disease screening,” “celiac disease vaccine,” and “celiac disease surgery.”


 

Current Search Term:

“Celiac Disease (Gluten-Free Diet)”

Add Comments or Questions



Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms


Condition:   Celiac Disease
Interventions:   Dietary Supplement: Bifidobacterium infantis NLS super strain (Natren LIFE START®2);   Other: Placebo
Sponsors:   Global Institute of Probiotics;   Dr. C. Bonorino Udaondo Gastroenterology Hospital;   Research Institute, Universidad del Salvador;   Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires
Recruiting


Celiac Disease Prevention With Probiotics


Condition:   Celiac Disease in Children
Interventions:   Dietary Supplement: Probiotic;   Dietary Supplement: Placebo
Sponsor:   Lund University
Completed


In Vivo Effects of the Gluten Friendly Bread in Coeliac Disease


Condition:   Celiac Disease
Intervention:   Dietary Supplement: Gluten Friendly bread
Sponsor:   University of Roehampton
Recruiting


Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance


Condition:   Celiac Disease
Interventions:   Diagnostic Test: Mucosal Impedance Catheter;   Diagnostic Test: Blood sample
Sponsor:   Vanderbilt University Medical Center
Enrolling by invitation


Evidence-based Screening Strategies for Celiac Disease


Condition:   Celiac Disease
Intervention:   Diagnostic Test: Celiac disease antibody screening
Sponsor:   Katri Kaukinen
Not yet recruiting


Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease


Condition:   Celiac Disease
Interventions:   Device: Lateral-viewing CapsoCam device;   Device: Axial-viewing capsule
Sponsors:   Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico;   IRCCS Policlinico S. Donato
Recruiting


Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting


Condition:   Coeliac Disease
Intervention:   Device: Simtomax
Sponsor:   Sheffield Teaching Hospitals NHS Foundation Trust
Recruiting


A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease


Condition:   Celiac Disease
Interventions:   Biological: AMG 714;   Biological: Placebo
Sponsor:   Celimmune
Active, not recruiting


Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease


Condition:   Celiac Disease
Interventions:   Biological: Nexvax2;   Biological: Nexvax2 placebo
Sponsor:   ImmusanT, Inc.
Completed


Pancreatic Enzyme Supplementation for Celiac Disease


Condition:   Celiac Disease
Intervention:   Drug: pancrelipase
Sponsors:   Beth Israel Deaconess Medical Center;   Actavis Inc.
Recruiting


Gluten Challenge in Celiac Disease


Condition:   Celiac Disease
Intervention:   Dietary Supplement: Gluten challenge
Sponsors:   Oslo University Hospital;   Stiftelsen Helse og Rehabilitering;   Helse Sor-Ost
Recruiting


Cytokine Profile in Children With Celiac Disease


Condition:   Celiac Disease
Interventions:   Drug: Bifidobacterium breve;   Drug: Placebo (for Bifidobacterium breve)
Sponsors:   University Clinical Centre, Maribor;   Slovenian Research Agency
Completed


Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay.


Condition:   Celiac Disease
Intervention:  
Sponsor:   University of Palermo
Recruiting


Immune Response in Celiac Disease on In-vitro Gluten Challenge


Condition:   Celiac Disease
Intervention:  
Sponsor:   Beth Israel Deaconess Medical Center
Enrolling by invitation


Celiac Disease Screening


Condition:   Celiac Disease
Intervention:   Other: gluten free diet
Sponsor:   Beth Israel Deaconess Medical Center
Terminated


Screen-detected Coeliac Disease, a Population Based Study


Condition:   Celiac Disease
Intervention:   Other: Gluten-free diet
Sponsors:   University Hospital of North Norway;   The Norwegian Coeliac Society;   The Gastrointestinal Research Foundation, University Hospital of NorthNorway
Active, not recruiting


Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults


Condition:   Celiac Disease
Intervention:   Device: MGH OFDI Imaging
Sponsor:   Massachusetts General Hospital
Completed


A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease


Condition:   Celiac Disease
Interventions:   Drug: Larazotide Acetate;   Drug: placebo
Sponsors:   Innovate Biopharmaceuticals;   Teva Pharmaceuticals USA
Completed


Prospective Study of Undiagnosed Celiac Disease


Condition:   Celiac Disease
Intervention:   Other: Dietary instruction
Sponsor:   Mayo Clinic
Completed


Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease


Condition:   Celiac Disease
Interventions:   Drug: Rifaximin;   Drug: Placebo
Sponsors:   Columbia University;   Valeant Pharmaceuticals International, Inc.
Completed


Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet


Condition:   Celiac Disease
Intervention:  
Sponsor:   Hadassah Medical Organization
Completed


Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease


Condition:   Celiac Disease
Interventions:   Drug: Larazotide acetate;   Drug: Placebo;   Dietary Supplement: Gluten 900 mg
Sponsor:   Innovate Biopharmaceuticals
Completed


Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease


Condition:   Celiac Disease
Interventions:   Drug: larazotide acetate;   Drug: placebo
Sponsor:   Innovate Biopharmaceuticals
Completed


Safety Study of Larazotide Acetate to Treat Celiac Disease.


Condition:   Celiac Disease
Intervention:   Drug: larazotide acetate
Sponsor:   Innovate Biopharmaceuticals
Completed


Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects


Condition:   Celiac Disease
Interventions:   Drug: larazotide acetate;   Drug: Placebo
Sponsor:   Innovate Biopharmaceuticals
Completed

Refine Your Search Advanced Search