Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1
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ClinicalTrials.gov Identifier: NCT02764931 |
Recruitment Status :
Completed
First Posted : May 6, 2016
Last Update Posted : November 4, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
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Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption | Other: Gluten free oats and gastrointestinal health | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1 |
Actual Study Start Date : | May 1, 2018 |
Actual Primary Completion Date : | August 1, 2019 |
Actual Study Completion Date : | November 22, 2019 |

Arm | Intervention/treatment |
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Experimental: Oat meal 1
A single gluten-free oat containing meal number 1 before ingesting the SmartPill capsule. Dietary intervention. Gluten free oats and gastrointestinal health
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Other: Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design |
Placebo Comparator: Placebo meal
A single meal which does not contain oats before ingesting the SmartPill capsule. Dietary intervention: gluten-free oats and gastrointestinal health.
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Other: Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design |
Experimental: Oat meal 2
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
Subjects will be served 3 different test meals in a randomized order in the cross-over design |
- Pressure, temperature and pH in the intestinal tract [ Time Frame: Day 0-5 ]Pressure, temperature and pH in the intestinal tract as measured by ingestible SmartPill capsule
- Gastrointestinal symptoms (self-reported) [ Time Frame: Day 0-5 ]Gastrointestinal symptoms (self-reported) as measured by a questionnaire

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764931
Finland | |
Department of Biochemistry, University of Turku | |
Turku, Finland, 20014 |
Principal Investigator: | Kaisa Linderborg, PhD | Associate professor |
Responsible Party: | Kaisa Linderborg, Professor of Molecular Food Sciences (acting), University of Turku |
ClinicalTrials.gov Identifier: | NCT02764931 |
Other Study ID Numbers: |
KAURA1 |
First Posted: | May 6, 2016 Key Record Dates |
Last Update Posted: | November 4, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |