Celiac DiseaseCELIPREVNCT00639444
Risk of Celiac Disease and Age at Gluten Introduction
A study testing gluten-free, normocaloric diet from 6 to 12 months in people with Celiac Disease, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development in infants with a first-degree relative affected by CD. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Celiac Disease
- What is being tested?
- gluten-free, normocaloric diet from 6 to 12 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to Nov 2013
- 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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning
The purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development in infants with a first-degree relative affected by CD.
Read the detailed description
We undertook a prospective study to establish the incidence of CD autoimmunity related to the timing of gluten exposure in at-risk infants. Infants at family risk for CD (at least one first-degree relative affected) are enrolled in this prospective, multicentre, intervention study conducted in Italy. Infants are randomly assigned to introduce gluten at either 4-6 or 12 months (groups A and B, respectively) and then enter a follow-up period of 5 years. Duration of breastfeeding and types of formulas, adherence to the dietary plan, amount of gluten administered, and clinical data are collected by phone or direct interview at 4, 7, 9, and 12 months of age. HLA (Human Leucocyte Antigene) status and CD serology (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of age.
- Conditions
- Celiac Disease
- Being tested
- gluten-free, normocaloric diet from 6 to 12 months
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluten-free, normocaloric diet from 6 to 12 monthsDietary supplement
Also called gluten-free products
Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet
| Study group | Role | What they receive |
|---|---|---|
| Gluten free diet | Active comparator | the intervention in this group is keeping a gluten-free diet from 0 to 12 months Receives: Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months |
| Gluten containing diet | No intervention | infants in this group are started on gluten-containing cereals at 6 months (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of active CD
Measured: 5 years of age
Secondary outcomes (1)
prevalence of CD-related autoantibodies (IgA anti-transglutaminase)
Measured: age 2, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana Celiachia (AIC), Menarini Group
- Responsible party
- Principal investigator, Carlo Catassi, M.D., Università Politecnica delle Marche
- Investigators
- Carlo Catassi, MD, Principal investigator, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639444
- Sponsor's protocol ID
- UPM-CE 204332
- Acronym
- CELIPREV
- Status last verified
- Dec 2013
- First submitted
- 14 Mar 2008
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lionetti E, Castellaneta S, Pulvirenti A, Tonutti E, Francavilla R, Fasano A, Catassi C; Italian Working Group of Weaning and Celiac Disease Risk. Prevalence and natural history of potential celiac disease in at-family-risk infants prospectively investigated from birth. J Pediatr. 2012 Nov;161(5):908-14. doi: 10.1016/j.jpeds.2012.05.008. Epub 2012 Jun 15.
PubMed 22704250Lionetti E, Castellaneta S, Francavilla R, Pulvirenti A, Tonutti E, Amarri S, Barbato M, Barbera C, Barera G, Bellantoni A, Castellano E, Guariso G, Limongelli MG, Pellegrino S, Polloni C, Ughi C, Zuin G, Fasano A, Catassi C; SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition) Working Group on Weaning and CD Risk. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med. 2014 Oct 2;371(14):1295-303. doi: 10.1056/NEJMoa1400697.
PubMed 25271602
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning
- ClinicalTrials.gov ID
- NCT00639444
- Acronym / sponsor ID
- CELIPREV / UPM-CE 204332
- Conditions
- Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Collaborators
- Associazione Italiana Celiachia (AIC), Menarini Group
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Mar 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.
The purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development in infants with a first-degree relative affected by CD.
Detailed description
We undertook a prospective study to establish the incidence of CD autoimmunity related to the timing of gluten exposure in at-risk infants. Infants at family risk for CD (at least one first-degree relative affected) are enrolled in this prospective, multicentre, intervention study conducted in Italy. Infants are randomly assigned to introduce gluten at either 4-6 or 12 months (groups A and B, respectively) and then enter a follow-up period of 5 years. Duration of breastfeeding and types of formulas, adherence to the dietary plan, amount of gluten administered, and clinical data are collected by phone or direct interview at 4, 7, 9, and 12 months of age. HLA (Human Leucocyte Antigene) status and CD serology (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gluten free diet | Active comparator | Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 monthsthe intervention in this group is keeping a gluten-free diet from 0 to 12 months |
| Gluten containing diet | No intervention | –infants in this group are started on gluten-containing cereals at 6 months (control group) |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Key exclusion criteria (0 listed)
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, normocaloric diet from 6 to 12 monthsAlso: gluten-free productsGluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet | Dietary supplement | Gluten free diet |
Primary outcome
prevalence of active CD
Time frame: 5 years of age
1 secondary outcome
prevalence of CD-related autoantibodies (IgA anti-transglutaminase)
Time frame: age 2, 3 and 5 years
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 10 Dec 2013.
- Background: PubMed 22704250Lionetti E, Castellaneta S, Pulvirenti A, Tonutti E, Francavilla R, Fasano A, Catassi C; Italian Working Group of Weaning and Celiac Disease Risk. Prevalence and natural history of potential celiac disease in at-family-risk infants prospectively investigated from birth. J Pediatr. 2012 Nov;161(5):908-14. doi: 10.1016/j.jpeds.2012.05.008. Epub 2012 Jun 15.
- Derived from this study: PubMed 25271602Lionetti E, Castellaneta S, Francavilla R, Pulvirenti A, Tonutti E, Amarri S, Barbato M, Barbera C, Barera G, Bellantoni A, Castellano E, Guariso G, Limongelli MG, Pellegrino S, Polloni C, Ughi C, Zuin G, Fasano A, Catassi C; SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition) Working Group on Weaning and CD Risk. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med. 2014 Oct 2;371(14):1295-303. doi: 10.1056/NEJMoa1400697.
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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, MD principal investigator
Università Politecnica delle Marche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten-free, normocaloric diet from 6 to 12 months in people with Celiac Disease, run by Università Politecnica delle Marche at 1 site 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 1 inclusion and 0 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 10 Dec 2013. 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 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?
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?
prevalence of active CD (time frame: 5 years of age). 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 NCT00639444, which also lists 2 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 10 Dec 2013.