Celiac DiseaseSafeOatDietNCT02612766
Safety and Tolerability of Oat Containing Gluten-free Diet
A study testing Pure, uncontaminated oats in people with Celiac Disease, run by Alfred Rusescu Institute for Mother and Child Care at 1 site in Romania.
Trial summary
The purpose of this study is to determine the safety and tolerability of oats in gluten free diet. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Pure, uncontaminated oats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRomania
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children over 4 years and adults with celiac disease (diagnosed according to current guidelines)
- Subject is able to fully participate in all aspects of this clinical trial
Who cannot join
- Known intolerance to oats
- Serious underlying disease other than CD which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET
The purpose of this study is to determine the safety and tolerability of oats in gluten free diet.
- Conditions
- Celiac Disease
- Being tested
- Pure, uncontaminated oats
- Keywords
- celiac disease, oat, gluten free diet
- Medical subject headings
- Celiac Disease, Gyrate Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure, uncontaminated oatsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats Receives: Dietary Supplement: Pure, uncontaminated oats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immunological activity of the disease measured by specific antibodies
Measured: After 6 weeks
Change in patient symptoms assessed by validated questionnaire
Measured: After 6 weeks
Secondary outcomes (1)
Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire
Measured: After 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfred Rusescu Institute for Mother and Child Care
- Sponsor type
- University, hospital or other
- Collaborators
- The National Research and Development Institute for Alimentary Bioresources, Bucharest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612766
- Sponsor's protocol ID
- PCCA2-111/2012
- Acronym
- SafeOatDiet
- Status last verified
- Aug 2017
- First submitted
- 11 Nov 2015
- Last updated
- 3 Aug 2017
- Results posted
- No
Publications
Kaukinen K, Collin P, Huhtala H, Maki M. Long-term consumption of oats in adult celiac disease patients. Nutrients. 2013 Nov 6;5(11):4380-9. doi: 10.3390/nu5114380.
PubMed 24201240Gatti S, Caporelli N, Galeazzi T, Francavilla R, Barbato M, Roggero P, Malamisura B, Iacono G, Budelli A, Gesuita R, Catassi C, Lionetti E. Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study. Nutrients. 2013 Nov 20;5(11):4653-64. doi: 10.3390/nu5114653.
PubMed 24264227Cooper SE, Kennedy NP, Mohamed BM, Abuzakouk M, Dunne J, Byrne G, McDonald G, Davies A, Edwards C, Kelly J, Feighery CF. Immunological indicators of coeliac disease activity are not altered by long-term oats challenge. Clin Exp Immunol. 2013 Mar;171(3):313-8. doi: 10.1111/cei.12014.
PubMed 23379438Tapsas D, Falth-Magnusson K, Hogberg L, Hammersjo JA, Hollen E. Swedish children with celiac disease comply well with a gluten-free diet, and most include oats without reporting any adverse effects: a long-term follow-up study. Nutr Res. 2014 May;34(5):436-41. doi: 10.1016/j.nutres.2014.04.006. Epub 2014 Apr 18.
PubMed 24916557Sjoberg V, Hollen E, Pietz G, Magnusson KE, Falth-Magnusson K, Sundstrom M, Holmgren Peterson K, Sandstrom O, Hernell O, Hammarstrom S, Hogberg L, Hammarstrom ML. Noncontaminated dietary oats may hamper normalization of the intestinal immune status in childhood celiac disease. Clin Transl Gastroenterol. 2014 Jun 26;5(6):e58. doi: 10.1038/ctg.2014.9.
PubMed 24964993Tjellstrom B, Stenhammar L, Sundqvist T, Falth-Magnusson K, Hollen E, Magnusson KE, Norin E, Midtvedt T, Hogberg L. The effects of oats on the function of gut microflora in children with coeliac disease. Aliment Pharmacol Ther. 2014 May;39(10):1156-60. doi: 10.1111/apt.12707. Epub 2014 Mar 24.
PubMed 24661128
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET
- ClinicalTrials.gov ID
- NCT02612766
- Acronym / sponsor ID
- SafeOatDiet / PCCA2-111/2012
- Conditions
- Celiac Disease
- Keywords
- celiac disease, oat, gluten free diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Alfred Rusescu Institute for Mother and Child CareUniversity, hospital or other
- Collaborators
- The National Research and Development Institute for Alimentary Bioresources, Bucharest
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Nov 2015 (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 purpose of this study is to determine the safety and tolerability of oats in gluten free diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Dietary Supplement: Pure, uncontaminated oatsThis is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Children over 4 years and adults with celiac disease (diagnosed according to current guidelines)
- Subject is able to fully participate in all aspects of this clinical trial
Key exclusion criteria (2 listed)
- Known intolerance to oats
- Serious underlying disease other than CD which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure, uncontaminated oats | Dietary supplement | Single Arm |
Primary outcome
Change in immunological activity of the disease measured by specific antibodies
Time frame: After 6 weeks
Change in patient symptoms assessed by validated questionnaire
Time frame: After 6 weeks
1 secondary outcome
Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire
Time frame: After 6 weeks
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 3 Aug 2017.
- Background: PubMed 24201240Kaukinen K, Collin P, Huhtala H, Maki M. Long-term consumption of oats in adult celiac disease patients. Nutrients. 2013 Nov 6;5(11):4380-9. doi: 10.3390/nu5114380.
- Background: PubMed 24264227Gatti S, Caporelli N, Galeazzi T, Francavilla R, Barbato M, Roggero P, Malamisura B, Iacono G, Budelli A, Gesuita R, Catassi C, Lionetti E. Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study. Nutrients. 2013 Nov 20;5(11):4653-64. doi: 10.3390/nu5114653.
- Background: PubMed 23379438Cooper SE, Kennedy NP, Mohamed BM, Abuzakouk M, Dunne J, Byrne G, McDonald G, Davies A, Edwards C, Kelly J, Feighery CF. Immunological indicators of coeliac disease activity are not altered by long-term oats challenge. Clin Exp Immunol. 2013 Mar;171(3):313-8. doi: 10.1111/cei.12014.
- Background: PubMed 24916557Tapsas D, Falth-Magnusson K, Hogberg L, Hammersjo JA, Hollen E. Swedish children with celiac disease comply well with a gluten-free diet, and most include oats without reporting any adverse effects: a long-term follow-up study. Nutr Res. 2014 May;34(5):436-41. doi: 10.1016/j.nutres.2014.04.006. Epub 2014 Apr 18.
- Background: PubMed 24964993Sjoberg V, Hollen E, Pietz G, Magnusson KE, Falth-Magnusson K, Sundstrom M, Holmgren Peterson K, Sandstrom O, Hernell O, Hammarstrom S, Hogberg L, Hammarstrom ML. Noncontaminated dietary oats may hamper normalization of the intestinal immune status in childhood celiac disease. Clin Transl Gastroenterol. 2014 Jun 26;5(6):e58. doi: 10.1038/ctg.2014.9.
- Background: PubMed 24661128Tjellstrom B, Stenhammar L, Sundqvist T, Falth-Magnusson K, Hollen E, Magnusson KE, Norin E, Midtvedt T, Hogberg L. The effects of oats on the function of gut microflora in children with coeliac disease. Aliment Pharmacol Ther. 2014 May;39(10):1156-60. doi: 10.1111/apt.12707. Epub 2014 Mar 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure, uncontaminated oats in people with Celiac Disease, run by Alfred Rusescu Institute for Mother and Child Care at 1 site in Romania.
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 2 inclusion and 2 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 3 Aug 2017. 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 Romania. 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?
Change in immunological activity of the disease measured by specific antibodies (time frame: After 6 weeks). 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?
On the ClinicalTrials.gov record for NCT02612766, which also lists 6 linked publications.
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 3 Aug 2017.