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

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ClinicalTrials.gov Identifier: NCT02764931
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Kaisa Linderborg, University of Turku

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 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.


Condition or disease Intervention/treatment Phase
Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption Other: Gluten free oats and gastrointestinal health Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Oat meal 1
A single gluten-free oat containing meal number 1 before ingesting the SmartPill capsule. Dietary intervention. Gluten free oats and gastrointestinal health
Other: Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design

Placebo Comparator: Placebo meal
A single meal which does not contain oats before ingesting the SmartPill capsule. Dietary intervention: gluten-free oats and gastrointestinal health.
Other: Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design

Experimental: Oat meal 2
A single gluten-free oat containing meal number 2 before ingesting the SmartPill capsule. Dietary intervention. Gluten free oats and gastrointestinal health
Other: Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design




Primary Outcome Measures :
  1. Pressure, temperature and pH in the intestinal tract [ Time Frame: Day 0-5 ]
    Pressure, temperature and pH in the intestinal tract as measured by ingestible SmartPill capsule


Secondary Outcome Measures :
  1. Gastrointestinal symptoms (self-reported) [ Time Frame: Day 0-5 ]
    Gastrointestinal symptoms (self-reported) as measured by a questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764931


Contacts
Contact: Lotta Nylund, PhD +358503373862 lotta.nylund@utu.fi

Locations
Finland
Department of Biochemistry, University of Turku Recruiting
Turku, Finland, 20014
Contact: Kaisa M Linderborg, PhD    +358 2 333 6872    kaisa.linderborg@utu.fi   
Principal Investigator: Kaisa M Linderborg, PhD         
Sponsors and Collaborators
University of Turku
Investigators
Principal Investigator: Kaisa Linderborg, PhD Associate professor

Responsible Party: Kaisa Linderborg, Professor of Molecular Food Sciences (acting), University of Turku
ClinicalTrials.gov Identifier: NCT02764931     History of Changes
Other Study ID Numbers: KAURA1
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases