Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1
Condition: Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption
MeSH terms: Celiac Disease
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Gluten free oats and gastrointestinal health
Intervention type(s): Other
Intervention description(s): Subjects will be served 3 different test meals in a randomized order in the cross-over design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science