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

Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764931
• Other study ID #: KAURA1
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: November 22, 2019

Study information

• Verified date: November 2020
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 22, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Intervention

Other:
• Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design

Locations

Country	Name	City	State
Finland	Department of Biochemistry, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gastrointestinal symptoms (self-reported)	Gastrointestinal symptoms (self-reported) as measured by a questionnaire	Day 0-5