Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02761785
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2016-05-03
Brief Title:
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease Part 2
Sponsor:
University of Turku
Organization:
University of Turku
Study Overview
Official Title:
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease Part 2
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 oatplacebo 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
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 oatplacebo 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None