Unidentified Gastrointestinal Symptoms Following Gluten-free Oats ConsumptionNCT02761785
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2
An observational study of Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption, run by University of Turku at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption
- How many people
- 49 participants
- Where
- 1 siteFinland
- Study dates
- 29 May 2017to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Group 1:Celiac patients who have self-reported gastrointestinal symptoms after ingestion of gluten-free oats Group 2: Celiac patients who include gluten-free oats in their diet and have no symptoms related to oats Group 3: Non-celiac gluten sensitive subjects Group 4: Healthy controls (without celiac disease) who include oats in their diet
Who may be able to join
- Celiac disease diagnosed with duodenal biopsy (only celiac groups)
- In remission and maintained gluten-free diet >1 year (only celiac groups)
- Usage of oats in their diet (only oat-using celiacs and healthy controls)
- BMI 18,5 - 30
- Normal liver, thyroid and kidney functions
Who cannot join
- Medication that majorly affects GI tract (e.g. laxatives, antacids)
- Antibiotic treatment within the last 6 months
- Blood donation or participating in another clinical trial within the last month
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Celiacs with oat-related symptoms | Celiac patients who have self-reported gastrointestinal symptoms after ingestion of gluten-free oats | |
| Celiacs without oat-related symptoms | Celiac patients who include gluten-free oats in their diet and have no symptoms related to oats | |
| Healthy controls | Healthy controls (without celiac disease) who include oats in their diet | |
| Non-celiac gluten sensitive subjects | Subjects with manifestations precipitated by ingestion of gluten in whom celiac disease and wheat allergy are excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota composition
Fecal microbiota diversity and composition analyzed from fecal sample
Measured: Measured from single time point sampling
Metabolic status
Metabolic status analyzed by the amount of metabolic products found in fecal, urine and serum samples
Measured: Measured from single time point sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start29 May 2017
- Primary completion15 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unidentified Gastrointestinal Symptoms Following Gluten-free Oats ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaisa Linderborg, University of Turku
- Investigators
- Kaisa Linderborg, PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761785
- Sponsor's protocol ID
- KAURA2
- Status last verified
- Oct 2018
- First submitted
- 3 May 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2
- ClinicalTrials.gov ID
- NCT02761785
- Acronym / sponsor ID
- KAURA2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Celiacs with oat-related symptoms | – | –Celiac patients who have self-reported gastrointestinal symptoms after ingestion of gluten-free oats |
| Celiacs without oat-related symptoms | – | –Celiac patients who include gluten-free oats in their diet and have no symptoms related to oats |
| Healthy controls | – | –Healthy controls (without celiac disease) who include oats in their diet |
| Non-celiac gluten sensitive subjects | – | –Subjects with manifestations precipitated by ingestion of gluten in whom celiac disease and wheat allergy are excluded. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group 1:Celiac patients who have self-reported gastrointestinal symptoms after ingestion of gluten-free oats Group 2: Celiac patients who include gluten-free oats in their diet and have no symptoms related to oats Group 3: Non-celiac gluten sensitive subjects Group 4: Healthy controls (without celiac disease) who include oats in their diet
Key inclusion criteria (5 listed)
- Celiac disease diagnosed with duodenal biopsy (only celiac groups)
- In remission and maintained gluten-free diet >1 year (only celiac groups)
- Usage of oats in their diet (only oat-using celiacs and healthy controls)
- BMI 18,5 - 30
- Normal liver, thyroid and kidney functions
Key exclusion criteria (3 listed)
- Medication that majorly affects GI tract (e.g. laxatives, antacids)
- Antibiotic treatment within the last 6 months
- Blood donation or participating in another clinical trial within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal microbiota composition
Time frame: Measured from single time point sampling
Fecal microbiota diversity and composition analyzed from fecal sample
Metabolic status
Time frame: Measured from single time point sampling
Metabolic status analyzed by the amount of metabolic products found in fecal, urine and serum samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaisa Linderborg, PhD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiota composition (time frame: Measured from single time point sampling). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.