Clinical and Nutritional Safety.NCT00808301
Oat Products in the Treatment of Coeliac Disease in Children
A study testing Gluten-free products in people with Clinical and Nutritional Safety., run by Heinz Italia SpA at 7 sites in Italy.
Trial summary
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years. The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of… Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Clinical and Nutritional Safety.
- What is being tested?
- Gluten-free products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesItaly
- Study dates
- Jan 2009to Oct 2015
- 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 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- diagnosis not confirmed by intestinal biopsy, cases with little adherence to the treatment (anti-tTG positive at basal evaluation), cases of potential coeliac disease (completely normal mucous membrane), cases with an associated sieric IgA deficit, cases with associated diseases (es. diabetes type 1).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Università Politecnica delle Marche, Clinica Pediatrica
Ancona, 60123
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti"
Bari, 70124
Ospedale Centrale, Divisione di Pediatria
Bolzano, 39100
Azienda Ospedaliero-Universitaria "Policlinico Vittorio Emanuele"
Catania, CT, 95124
Ospedale Civile "S. Maria Incoronata dell'Olmo", Divisione di Pediatria
Cava de' Tirreni, Salerno, 84013
Azienda Ospedaliera "San Gerardo", Clinica Pediatrica
Monza, 20052
Azienda Policlinico "Umberto I" - Dip. di Pediatria - UOC di Gastroenterologia ed Epatologia Pediatrica
Roma, 00161
About this study
Official title: Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years.
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of Italian celiac patients in pediatric age.
Read the detailed description
Several clinical trials have demonstrated that most celiac patients, both of pediatric and of adult age, can take medium-high quantity of oat (50-100 g/day), without any negative clinical effects.
In a small number of cases intestinal dyspeptic disorders, especially meteorism, can be observed, particularly during the first weeks of oat intake. They are generally without clinical significance because they are a consequence of the increased fibre intake.
There are only few cases of "true" oats intolerance. The addition of oat improves the nutritional quality of the gluten-free diet, particularly due to the increased intake of fibre and some oligoelements (iron, zinc, tiamin, pholates) and expands the spectrum of food choices.
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years.
For the oat-based product to be considered suitable in the dieto-therapy of coeliac disease, the absence of gluten contamination and possibly the origin from a variety of oat which is without traces of gluten cross-reactive peptides must be guaranteed.
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of Italian celiac patients in pediatric age.
- Conditions
- Clinical and Nutritional Safety.
- Being tested
- Gluten-free products
- Keywords
- Coeliac disease, Oat
- 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.
Gluten-free productsOther
Also called BiAglut
Gluten-free bakery products containing oatmeal.
| Study group | Role | What they receive |
|---|---|---|
| A/B | Other | This is a cross-over design, i.e. each patient is treated with either oat or control products in different times. Receives: Other: Gluten-free products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical safety through serological markers of coeliac disease and intestinal wall integrity, clinical and bioumoral parameters of nutrition status, frequency and clinical type of dyspeptic disorders or other adverse reactions.
Measured: Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study.
Secondary outcomes (1)
Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire.
Measured: Product liking questionnaire after 6 months and 15 months from the beginning of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2014
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Clinical and Nutritional Safety.Studies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinz Italia SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Catassi, Prof., Principal investigator, Università Politecnica delle Marche - Clinica Pediatrica - AnconaRuggiero Francavilla, Dr., Principal investigator, Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" - BariKlaus Pittschieler, Prof., Principal investigator, Ospedale Centrale di BolzanoBasilio Malamisura, Prof., Principal investigator, Ospedale Civile "S. Maria Incoronata dell'Olmo" - Cava de' Tirreni (SA)Roberto Panceri, Dr., Principal investigator, Azienda Ospedaliera "San Gerardo" - MonzaMaria Barbato, Prof., Principal investigator, Azienda Policlinico Umberto IMario La Rosa, Prof., Principal investigator, Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele, Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808301
- Sponsor's protocol ID
- PLA-07-01
- Status last verified
- Mar 2015
- First submitted
- 12 Dec 2008
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. No abstract available. English, Spanish.
PubMed 15954735Fasano A, Catassi C. Current approaches to diagnosis and treatment of celiac disease: an evolving spectrum. Gastroenterology. 2001 Feb;120(3):636-51. doi: 10.1053/gast.2001.22123.
PubMed 11179241Reunala T, Collin P, Holm K, Pikkarainen P, Miettinen A, Vuolteenaho N, Maki M. Tolerance to oats in dermatitis herpetiformis. Gut. 1998 Oct;43(4):490-3. doi: 10.1136/gut.43.4.490.
PubMed 9824575Hoffenberg EJ, Haas J, Drescher A, Barnhurst R, Osberg I, Bao F, Eisenbarth G. A trial of oats in children with newly diagnosed celiac disease. J Pediatr. 2000 Sep;137(3):361-6. doi: 10.1067/mpd.2000.109003.
PubMed 10969261Janatuinen EK, Kemppainen TA, Julkunen RJ, Kosma VM, Maki M, Heikkinen M, Uusitupa MI. No harm from five year ingestion of oats in coeliac disease. Gut. 2002 Mar;50(3):332-5. doi: 10.1136/gut.50.3.332.
PubMed 11839710Storsrud S, Olsson M, Arvidsson Lenner R, Nilsson LA, Nilsson O, Kilander A. Adult coeliac patients do tolerate large amounts of oats. Eur J Clin Nutr. 2003 Jan;57(1):163-9. doi: 10.1038/sj.ejcn.1601525.
PubMed 12548312Lundin KE, Nilsen EM, Scott HG, Loberg EM, Gjoen A, Bratlie J, Skar V, Mendez E, Lovik A, Kett K. Oats induced villous atrophy in coeliac disease. Gut. 2003 Nov;52(11):1649-52. doi: 10.1136/gut.52.11.1649.
PubMed 14570737Hogberg L, Laurin P, Falth-Magnusson K, Grant C, Grodzinsky E, Jansson G, Ascher H, Browaldh L, Hammersjo JA, Lindberg E, Myrdal U, Stenhammar L. Oats to children with newly diagnosed coeliac disease: a randomised double blind study. Gut. 2004 May;53(5):649-54. doi: 10.1136/gut.2003.026948.
PubMed 15082581Arentz-Hansen H, Fleckenstein B, Molberg O, Scott H, Koning F, Jung G, Roepstorff P, Lundin KE, Sollid LM. The molecular basis for oat intolerance in patients with celiac disease. PLoS Med. 2004 Oct;1(1):e1. doi: 10.1371/journal.pmed.0010001. Epub 2004 Oct 19.
PubMed 15526039Holm K, Maki M, Vuolteenaho N, Mustalahti K, Ashorn M, Ruuska T, Kaukinen K. Oats in the treatment of childhood coeliac disease: a 2-year controlled trial and a long-term clinical follow-up study. Aliment Pharmacol Ther. 2006 May 15;23(10):1463-72. doi: 10.1111/j.1365-2036.2006.02908.x.
PubMed 16669961Peraaho M, Collin P, Kaukinen K, Kekkonen L, Miettinen S, Maki M. Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. J Am Diet Assoc. 2004 Jul;104(7):1148-50. doi: 10.1016/j.jada.2004.04.025.
PubMed 15215774Garsed K, Scott BB. Can oats be taken in a gluten-free diet? A systematic review. Scand J Gastroenterol. 2007 Feb;42(2):171-8. doi: 10.1080/00365520600863944.
PubMed 17327936Storsrud S, Hulthen LR, Lenner RA. Beneficial effects of oats in the gluten-free diet of adults with special reference to nutrient status, symptoms and subjective experiences. Br J Nutr. 2003 Jul;90(1):101-7. doi: 10.1079/bjn2003872.
PubMed 12844381Thompson T. Gluten contamination of commercial oat products in the United States. N Engl J Med. 2004 Nov 4;351(19):2021-2. doi: 10.1056/NEJM200411043511924. No abstract available.
PubMed 15525734Hernando A, Mujico JR, Juanas D, Mendez E. Confirmation of the cereal type in oat products highly contaminated with gluten. J Am Diet Assoc. 2006 May;106(5):665; discussion 665-6. doi: 10.1016/j.jada.2006.03.024. No abstract available.
PubMed 16647318
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
- ClinicalTrials.gov ID
- NCT00808301
- Acronym / sponsor ID
- PLA-07-01
- Conditions
- Clinical and Nutritional Safety.
- Keywords
- Coeliac disease, Oat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heinz Italia SpAIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2015 (estimated)
- First posted
- 15 Dec 2008 (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.
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years.
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of Italian celiac patients in pediatric age.
Detailed description
Several clinical trials have demonstrated that most celiac patients, both of pediatric and of adult age, can take medium-high quantity of oat (50-100 g/day), without any negative clinical effects.
In a small number of cases intestinal dyspeptic disorders, especially meteorism, can be observed, particularly during the first weeks of oat intake. They are generally without clinical significance because they are a consequence of the increased fibre intake.
There are only few cases of "true" oats intolerance. The addition of oat improves the nutritional quality of the gluten-free diet, particularly due to the increased intake of fibre and some oligoelements (iron, zinc, tiamin, pholates) and expands the spectrum of food choices.
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years.
For the oat-based product to be considered suitable in the dieto-therapy of coeliac disease, the absence of gluten contamination and possibly the origin from a variety of oat which is without traces of gluten cross-reactive peptides must be guaranteed.
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of Italian celiac patients in pediatric age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A/B | Other | Other: Gluten-free productsThis is a cross-over design, i.e. each patient is treated with either oat or control products in different times. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- diagnosis not confirmed by intestinal biopsy, cases with little adherence to the treatment (anti-tTG positive at basal evaluation), cases of potential coeliac disease (completely normal mucous membrane), cases with an associated sieric IgA deficit, cases with associated diseases (es. diabetes type 1).
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 |
|---|---|---|
| Gluten-free productsAlso: BiAglutGluten-free bakery products containing oatmeal. | Other | A/B |
Primary outcome
Clinical safety through serological markers of coeliac disease and intestinal wall integrity, clinical and bioumoral parameters of nutrition status, frequency and clinical type of dyspeptic disorders or other adverse reactions.
Time frame: Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study.
1 secondary outcome
Liking of gluten-free products containing oatmeal is evaluated through a product liking questionnaire.
Time frame: Product liking questionnaire after 6 months and 15 months from the beginning of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Background: PubMed 15954735Catassi C. The world map of celiac disease. Acta Gastroenterol Latinoam. 2005;35(1):37-55. No abstract available. English, Spanish.
- Background: PubMed 11179241Fasano A, Catassi C. Current approaches to diagnosis and treatment of celiac disease: an evolving spectrum. Gastroenterology. 2001 Feb;120(3):636-51. doi: 10.1053/gast.2001.22123.
- Background: PubMed 9824575Reunala T, Collin P, Holm K, Pikkarainen P, Miettinen A, Vuolteenaho N, Maki M. Tolerance to oats in dermatitis herpetiformis. Gut. 1998 Oct;43(4):490-3. doi: 10.1136/gut.43.4.490.
- Background: PubMed 10969261Hoffenberg EJ, Haas J, Drescher A, Barnhurst R, Osberg I, Bao F, Eisenbarth G. A trial of oats in children with newly diagnosed celiac disease. J Pediatr. 2000 Sep;137(3):361-6. doi: 10.1067/mpd.2000.109003.
- Background: PubMed 11839710Janatuinen EK, Kemppainen TA, Julkunen RJ, Kosma VM, Maki M, Heikkinen M, Uusitupa MI. No harm from five year ingestion of oats in coeliac disease. Gut. 2002 Mar;50(3):332-5. doi: 10.1136/gut.50.3.332.
- Background: PubMed 12548312Storsrud S, Olsson M, Arvidsson Lenner R, Nilsson LA, Nilsson O, Kilander A. Adult coeliac patients do tolerate large amounts of oats. Eur J Clin Nutr. 2003 Jan;57(1):163-9. doi: 10.1038/sj.ejcn.1601525.
- Background: PubMed 14570737Lundin KE, Nilsen EM, Scott HG, Loberg EM, Gjoen A, Bratlie J, Skar V, Mendez E, Lovik A, Kett K. Oats induced villous atrophy in coeliac disease. Gut. 2003 Nov;52(11):1649-52. doi: 10.1136/gut.52.11.1649.
- Background: PubMed 15082581Hogberg L, Laurin P, Falth-Magnusson K, Grant C, Grodzinsky E, Jansson G, Ascher H, Browaldh L, Hammersjo JA, Lindberg E, Myrdal U, Stenhammar L. Oats to children with newly diagnosed coeliac disease: a randomised double blind study. Gut. 2004 May;53(5):649-54. doi: 10.1136/gut.2003.026948.
- Background: PubMed 15526039Arentz-Hansen H, Fleckenstein B, Molberg O, Scott H, Koning F, Jung G, Roepstorff P, Lundin KE, Sollid LM. The molecular basis for oat intolerance in patients with celiac disease. PLoS Med. 2004 Oct;1(1):e1. doi: 10.1371/journal.pmed.0010001. Epub 2004 Oct 19.
- Background: PubMed 16669961Holm K, Maki M, Vuolteenaho N, Mustalahti K, Ashorn M, Ruuska T, Kaukinen K. Oats in the treatment of childhood coeliac disease: a 2-year controlled trial and a long-term clinical follow-up study. Aliment Pharmacol Ther. 2006 May 15;23(10):1463-72. doi: 10.1111/j.1365-2036.2006.02908.x.
- Background: PubMed 15215774Peraaho M, Collin P, Kaukinen K, Kekkonen L, Miettinen S, Maki M. Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. J Am Diet Assoc. 2004 Jul;104(7):1148-50. doi: 10.1016/j.jada.2004.04.025.
- Background: PubMed 17327936Garsed K, Scott BB. Can oats be taken in a gluten-free diet? A systematic review. Scand J Gastroenterol. 2007 Feb;42(2):171-8. doi: 10.1080/00365520600863944.
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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.
Carlo Catassi, Prof. principal investigator
Università Politecnica delle Marche - Clinica Pediatrica - Ancona
Ruggiero Francavilla, Dr. principal investigator
Ospedale Policlinico Consorziale, Clinica Pediatrica "B.Trambusti" - Bari
Klaus Pittschieler, Prof. principal investigator
Ospedale Centrale di Bolzano
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free products in people with Clinical and Nutritional Safety., run by Heinz Italia SpA at 7 sites in Italy.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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?
Results are not available in the source record.
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?
Clinical safety through serological markers of coeliac disease and intestinal wall integrity, clinical and bioumoral parameters of nutrition status, frequency and clinical type of dyspeptic disorders or other adverse reactions. (time frame: Controls at recruiting, after 3, 6, 9, 12, 15 months from the beginning of the study.). 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 NCT00808301, which also lists 18 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 18 Mar 2015.