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

NCT ID: NCT02764931

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-11-22

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.

Conditions

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Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Gluten free oats and gastrointestinal health

Intervention Type OTHER

Subjects will be served 3 different test meals in a randomized order in the cross-over design

Placebo meal

A single meal which does not contain oats before ingesting the SmartPill capsule. Dietary intervention: gluten-free oats and gastrointestinal health.

Group Type PLACEBO_COMPARATOR

Gluten free oats and gastrointestinal health

Intervention Type OTHER

Subjects will be served 3 different test meals in a randomized order in the cross-over design

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

Group Type EXPERIMENTAL

Gluten free oats and gastrointestinal health

Intervention Type OTHER

Subjects will be served 3 different test meals in a randomized order in the cross-over design

Interventions

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Gluten free oats and gastrointestinal health

Subjects will be served 3 different test meals in a randomized order in the cross-over design

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Kaisa Linderborg

Professor of Molecular Food Sciences (acting)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaisa Linderborg, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

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Department of Biochemistry, University of Turku

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KAURA1

Identifier Type: -

Identifier Source: org_study_id