Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption Clinical Trial
Official title:
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02764931 -
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1
|
N/A |