Completed

NCT Number: NCT02764931

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

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.

Completed

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Key information

Conditions

Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biochemistry, University of Turku

Turku, 20014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan