Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Infections

Ear, Nose, and Throat Diseases

Diseases and Abnormalities at or Before Birth

Neoplasms

Digestive System Diseases

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Dermatitis

Asthma

Hypersensitivity

Food Hypersensitivity

Rhinitis

Rhinitis, Allergic

Dermatitis, Atopic

Eczema

Mastocytosis

Esophagitis

Eosinophilic Esophagitis

Peanut Hypersensitivity

Gastroenteritis

Respiratory Tract Diseases

Respiratory Hypersensitivity

Hypersensitivity, Immediate

Skin Diseases

Communicable Diseases

Respiratory Tract Infections

Nose Diseases

Otorhinolaryngologic Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Mast Cell Activation Disorders

Eosinophilic Gastroenteritis

Kelly D Stone, M.D.

This study will evaluate and follow patients with various allergic, hypersensitivity and inflammatory disorders. The protocol is not designed to test new treatments; patients will be managed with standard of care therapies. Participants may be referred to other current NIAID protocols as appropriate or to new studies as they are developed, but will not be required to join another study.

Patients with allergic, hypersensitivity or inflammatory disorders between the ages of 3 years and 80 years may be eligible for this study. Conditions of interest include, but are not limited to, asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy.

Participants will have a medical history and physical examination, plus standard tests for diagnosing and treating their specific disorder. Tests may include routine blood and urine studies, X-rays or other imaging studies, allergy skin tests and lung function tests. Blood samples may be collected for research on immune system cells and other substances involved in immune function. Generally, about 2 to 6 tablespoons will be drawn at a time, but no more than 16 ounces will be collected over a 6-week period.

NIH does not provide emergency medical treatment or treatment for other, unrelated conditions the patient may have. Therefore, patients must maintain a personal physician for these purposes.

Allergic, hypersensitivity and inflammatory disorders, including but not limited to asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy are exceedingly common disorders. The pathogenesis of these various disorders are being investigated under a number of Laboratory of Allergic Diseases clinical research protocols. This protocol is an evaluation and long term follow-up protocol of such disorders, for the purposes of maintaining a group of patients on which LAD investigators draw for our other various protocols. The patients admitted under this protocol also provide training and experience for members of the NIAID Allergy and Immunology fellowship training programs.

Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders

Evaluation and Long Term Follow-up of Patients With Allergic and Inflammatory Disorders

National Institute of Allergy and Infectious Diseases (NIAID)

Nutritional and Metabolic Diseases

Stomach Neoplasms

Syndrome

Esophageal Neoplasms

Obesity

Irritable Bowel Syndrome

Crohn Disease

Gastrointestinal Diseases

Gastroesophageal Reflux

Colonic Polyps

Colitis

Colitis, Ulcerative

Ulcer

Gallstones

Cholelithiasis

Cholecystolithiasis

Celiac Disease

Polyps

Barrett Esophagus

Metaplasia

Gastritis

Colitis, Microscopic

Stomach Ulcer

Duodenal Ulcer

Colitis, Lymphocytic

Stomach Diseases

Inflammatory Bowel Diseases

Intestinal Diseases

Colonic Diseases

Esophageal Diseases

Colonic Diseases, Functional

Precancerous Conditions

Eosinophilia

Leukocyte Disorders

Hematologic Diseases

Biliary Tract Diseases

Gallbladder Diseases

Calculi

Pathological Conditions, Anatomical

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Peptic Ulcer

Duodenal Diseases

Malabsorption Syndromes

Metabolic Diseases

Stomach Cancer

Esophageal Cancer

Hematinics

All Drugs and Chemicals

Herbal and Botanical

Liver Extracts

Cola

Participants with Eosinophilic esophagitis

Participants with Gastroesophageal Reflux Disease (GERD).

Participants with intestinal metaplasia (risk factor for esophageal cancer).

Participants with Lymphocytic/Microscopic Colitis.

Momchilo Vuyisich

This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

This is a longitudinal, observational study whose main goal is to identify the human and microbial determinants of gastrointestinal diseases. Molecular and metadata will be collected from a large study population at multiple time points. Machine learning will be applied to all data, and models will be evaluated for development of novel diagnostic and therapeutic tools.

Systems Biology of Gastrointestinal and Related Diseases

Identification of biomarkers that indicate gastrointestinal diseases.

Identification of microbial species that indicate gastrointestinal disease.

Prediction of the efficacy of a biologic medication against IBD based on molecular data and metadata.

Development of a molecular test for C. difficile infection (CDI)

Quantification of changes observed in the microbiome post colonoscopy.

Viome

Subject will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system

Subjects will swallow a SECM capsule and the SECM imaging will be performed

SECM capsule

Anita Chung, RN

Nitasha Bhat, MD

Elizabeth Biddle, RN

Guillermo Tearney, MD, PhD

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

Eosinophilic esophagitis is an inflammatory condition of the esophagus that occurs in response to certain foods or allergens. Approximately 300,000 people in the US have EoE, the incidence of newly diagnosed EoE is \~30,000/year, and EoE is found in 5-10% of all patients undergoing upper endoscopy. EoE is associated with debilitating symptoms, and is a common cause of dysphagia, strictures, and food impaction; it may even lead to esophageal perforation. Because of the impact of EoE on quality of life as well as the concern that this disease may progress to esophageal fibrosis with unknown long-term risks, experts recommend that EoE be treated until symptoms and eosinophilic infiltrate are resolved. Because the only objective method for diagnosing EoE is histopathologic assessment of multiple upper endoscopic biopsies, the processes of monitoring the esophagus during therapy and the food reintroduction involve a high number of repeat endoscopies. This process is both time consuming and frustrating for patients and their families. Because the endoscopic biopsy requires conscious sedation, it is also costly, exceeding $1000 per procedure. Given the rapid increase in the number of patients with this disease, there is a compelling need for a less invasive and more cost-effective means of identifying eosinophils in the esophagus.

Based on the extensive experience with Optical Coherence Tomography (OCT) and OFDI, the investigators at Tearney laboratory at MGH have developed a spectrally encoded confocal microscopy (SECM) technology that is able to acquire images at significantly higher frame rates than standard confocal microscopy. This SECM capability enables imaging of large portions of the esophagus at 2-µm resolution in realistic procedure times. Furthermore, the investigators at Tearney laboratory have created a tethered capsule SECM device that can be swallowed and used for EoE screening. The investigators at Tearney laboratory lab performed a pilot study using a SECM capsule on 58 subjects (2013-P-000863). The imaging was successful with no adverse or unanticipated events. SECM endoscopy capsule is similar to the approved endoscopy capsule.

A total of sixty (60) subjects will be recruited for this study. The imaging of the esophagus will be obtained. Subjects will not be sedated for the procedure.

The images obtained by the SECM capsule will be compared to the images obtained by the clinical endoscopy and biopsy. SECM imaging will be used for research purposes only and will not be used for diagnosis purposes.

Imaging of the Esophagus Using a SECM Capsule

comparing SECM imaging of the esophagus obtained with a SECM capsule to histopathology.

Massachusetts General Hospital

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders	NCT00557895	Allergy Asthma Allergic Rhinit... Mastocytosis Atopic Dermatit... Food Allergy		3 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Systems Biology of Gastrointestinal and Related Diseases	NCT05579444	Ulcerative Coli... Crohn Disease Obesity Colon Polyp Eosinophilic Es... GERD Gastro Esophage... Barrett Esophag... Esophageal Canc... Gastritis Gastric Ulcer Duodenal Ulcer Intestinal Meta... Gastric Cancer Lymphocytic Col... Microscopic Col... Celiac Sprue IBS Irritable Bowel... SIBO NAFLD Gallstone Disea...		18 Years -	Viome
Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders	NCT00557895	Allergy Asthma Allergic Rhinit... Mastocytosis Atopic Dermatit... Food Allergy		3 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Imaging of the Esophagus Using a SECM Capsule	NCT03546660	Eosinophilic Es... Barrett Esophag...	SECM capsule	12 Years -	Massachusetts General Hospital
Systems Biology of Gastrointestinal and Related Diseases	NCT05579444	Ulcerative Coli... Crohn Disease Obesity Colon Polyp Eosinophilic Es... GERD Gastro Esophage... Barrett Esophag... Esophageal Canc... Gastritis Gastric Ulcer Duodenal Ulcer Intestinal Meta... Gastric Cancer Lymphocytic Col... Microscopic Col... Celiac Sprue IBS Irritable Bowel... SIBO NAFLD Gallstone Disea...		18 Years -	Viome

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