Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1

Study Overview
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Brief Summary
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The research aims to investigate the effects of gluten-free oats to the gastrointestinal health in celiac disease patients and healthy subjects. The effects of gluten-free oats on the several intestinal parameters, on the composition of the gut microbiota as well as on the metabolic profile of celiac patients and healthy controls will be studied. The study is divided into two parts. Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (two different oat products and placebo) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and a blood sample. In addition, 36 hours urine samples will be collected. In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls will be recruited and they will be divided into four groups: oat-avoiding celiacs (1), oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4). Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a fecal sample will be collected from the subjects. The gut microbiota will be analyzed from the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing techniques.

Detailed Description
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Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (three different oat products) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat exposure the subjects will give a fecal and a blood sample. In addition, 24 hours urine samples will be collected.

Official Title
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Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1

Conditions
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Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Intervention / Treatment
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* Other: Gluten free oats and gastrointestinal health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Celiac disease and wheat allergy excluded by antigen test Age 18-65 BMI 18,5 - 30 Normal liver, thyroid and kidney functions Exclusion Criteria: Pacemaker or other implanted electronical device Crohn's disease, ulcerative colitis or acute diverticulitis Dysphagia or difficulties with swallowing Surgery on the GI tract within the last 3 months Intestinal obstruction Gastric bezoar Severe constipation Medication that majorly affects GI tract (e.g. laxatives, antacids) Antibiotic treatment within the last 6 months Blood donation or participating in a another clinical trial within the last month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oat meal 1<br>A single gluten-free oat containing meal number 1 before ingesting the SmartPill capsule. Dietary intervention. Gluten free oats and gastrointestinal health | Other: Gluten free oats and gastrointestinal health<br>* Subjects will be served 3 different test meals in a randomized order in the cross-over design<br>|
| Placebo Comparator: Placebo meal<br>A single meal which does not contain oats before ingesting the SmartPill capsule. Dietary intervention: gluten-free oats and gastrointestinal health. | Other: Gluten free oats and gastrointestinal health<br>* Subjects will be served 3 different test meals in a randomized order in the cross-over design<br>|
| Experimental: Oat meal 2<br>A single gluten-free oat containing meal number 2 before ingesting the SmartPill capsule. Dietary intervention. Gluten free oats and gastrointestinal health | Other: Gluten free oats and gastrointestinal health<br>* Subjects will be served 3 different test meals in a randomized order in the cross-over design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure, temperature and pH in the intestinal tract | Pressure, temperature and pH in the intestinal tract as measured by ingestible SmartPill capsule | Day 0-5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms (self-reported) | Gastrointestinal symptoms (self-reported) as measured by a questionnaire | Day 0-5 |