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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 : Completed
First Posted : May 6, 2016
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Kaisa Linderborg, University of Turku

Tracking Information
First Submitted Date  ICMJE May 3, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Pressure in the intestinal tract [ Time Frame: Day 0-5 ]
    Pressure in the intestinal tract as measured by ingestible Smart Pill capsule
  • Temperature in the intestinal tract [ Time Frame: Day 0-5 ]
    Temperature in the intestinal tract as measured by ingestible Smart Pill capsule
  • pH in the intestinal tract [ Time Frame: Day 0-5 ]
    pH in the intestinal tract as measured by ingestible Smart Pill capsule
  • Gastrointestinal symptoms (self-reported) [ Time Frame: Day 0-5 ]
    Gastrointestinal symptoms (self-reported) as measured by a questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
Gastrointestinal symptoms (self-reported) [ Time Frame: Day 0-5 ]
Gastrointestinal symptoms (self-reported) as measured by a questionnaire
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1
Official Title  ICMJE Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption
Intervention  ICMJE Other: Gluten free oats and gastrointestinal health
Subjects will be served 3 different test meals in a randomized order in the cross-over design
Study Arms  ICMJE
  • 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
    Intervention: Other: Gluten free oats and gastrointestinal health
  • 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.
    Intervention: Other: Gluten free oats and gastrointestinal health
  • 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
    Intervention: Other: Gluten free oats and gastrointestinal health
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2020)
14
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2016)
15
Actual Study Completion Date  ICMJE November 22, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764931
Other Study ID Numbers  ICMJE KAURA1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kaisa Linderborg, University of Turku
Study Sponsor  ICMJE University of Turku
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kaisa Linderborg, PhD Associate professor
PRS Account University of Turku
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP