Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2

NCT ID: NCT02761785

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2018-06-01

Brief Summary

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.

Conditions

Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Celiacs with oat-related symptoms

Celiac patients who have self-reported gastrointestinal symptoms after ingestion of gluten-free oats

No interventions assigned to this group

Celiacs without oat-related symptoms

Celiac patients who include gluten-free oats in their diet and have no symptoms related to oats

No interventions assigned to this group

Healthy controls

Healthy controls (without celiac disease) who include oats in their diet

No interventions assigned to this group

Non-celiac gluten sensitive subjects

Subjects with manifestations precipitated by ingestion of gluten in whom celiac disease and wheat allergy are excluded.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Celiac disease diagnosed with duodenal biopsy (only celiac groups)
• In remission and maintained gluten-free diet >1 year (only celiac groups)
• Usage of oats in their diet (only oat-using celiacs and healthy controls)
• BMI 18,5 - 30
• Normal liver, thyroid and kidney functions

Exclusion Criteria

• Medication that majorly affects GI tract (e.g. laxatives, antacids)
• Antibiotic treatment within the last 6 months
• Blood donation or participating in another clinical trial within the last month

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turku

OTHER

Sponsor Role: lead

Responsible Party

Kaisa Linderborg

Professor of Molecular Food Sciences (acting)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaisa Linderborg, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Department of Biochemistry, University of Turku

Turku, , Finland

Countries

Finland

Other Identifiers

KAURA2

Identifier Type: -

Identifier Source: org_study_id