Gluten Ingestion Biomarkers in Patients w Gluten Sensitivity and Healthy Controls Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study (NCGS)

Thomas Jefferson University

Status: Completed

Conditions: Non Celiac Gluten Sensitivity

Treatments: Dietary Supplement: Low dose Gluten; Dietary Supplement: High dose Gluten; Dietary Supplement: Lactose free placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02936297

IRB#16D.244

Details and patient eligibility

About

Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria include

• Patients > 18 years of age
• Patients willing to maintain gluten free diet for 6 weeks

Exclusion Criteria (NCGS):

• Patients < 18 years of age
• Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
• Patients with a diagnosis of inflammatory bowel disease
• Patients with a diagnosis of acute gastroenteritis
• Patients who are pregnant
• Type 1 Diabetes Mellitus

Exclusion criteria (healthy controls):

• NCGS
• Celiac disease
• Inflammatory bowel disease
• Irritable bowel syndrome
• Acute gastroenteritis
• Patients who are pregnant
• Type 1 Diabetes Mellitus

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Lactose free placebo

Placebo Comparator group

Description:

Lactose free placebo pill

Treatment:

Dietary Supplement: Lactose free placebo

Low dose Gluten (0.5g)

Active Comparator group

Description:

Low dose gluten pill

Treatment:

Dietary Supplement: Low dose Gluten

High Dose Gluten (2.0g)

Active Comparator group

Description:

High dose gluten pill

Treatment:

Dietary Supplement: High dose Gluten