NCT00819819

Brief Summary

The study will identify a cohort of infants at risk for celiac disease that can be followed on a long term basis for investigating the natural history the celiac disease based on the pattern of early nutrition. The study will investigate possible early feeding patterns including the timing of introduction to gluten that may protect at least in part from CD development in at risk infants.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

January 7, 2009

Last Update Submit

March 21, 2017

Conditions

Celiac DiseaseInfant Nutrition

Outcome Measures

Primary Outcomes (1)

  • To evaluate the primary prevention of early onset celiac disease and related autoimmunity phenomena by comparing the frequency of disease development according to two different patterns of gluten introduction in at risk infants

    5 years

Study Arms (2)

1 Gluten containing diet

ACTIVE COMPARATOR

Gluten added to diet at 6 months per American Academy of Pediatrics recommendations

Dietary Supplement: Gluten

2 Gluten free diet

ACTIVE COMPARATOR

Non gluten containing food starch added to diet from 6-12 months

Dietary Supplement: Gluten free diet

Interventions

GlutenDIETARY_SUPPLEMENT

Purified gluten from exaploid wheat introduced per American Academy of Pediatric Recommendations. Three grams from 6-9 months and 5 grams from 9-12 months. The 3-5 grams represents the mean daily intake of gluten during the second half of the first year in infants of different countries.

1 Gluten containing diet
Gluten free dietDIETARY_SUPPLEMENT

Non gluten containing starch added to diet. Three grams from 6-9 months and 5 grams from 9-12 months. After the age of 1 year all children will be allowed age appropriate unrestricted diet.

2 Gluten free diet

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborns and infants less than 6 months of age
  • First-degree relatives of patients affected with biopsy-proven CD
  • On exclusive milk diet (breast milk or formula)

You may not qualify if:

  • Infants that have gluten introduced in their diet before 5-6 months of age
  • Infants older than 6 months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital East

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (12)

  • Ivarsson A, Hernell O, Stenlund H, Persson LA. Breast-feeding protects against celiac disease. Am J Clin Nutr. 2002 May;75(5):914-21. doi: 10.1093/ajcn/75.5.914.

    PMID: 11976167BACKGROUND

  • Norris JM, Barriga K, Hoffenberg EJ, Taki I, Miao D, Haas JE, Emery LM, Sokol RJ, Erlich HA, Eisenbarth GS, Rewers M. Risk of celiac disease autoimmunity and timing of gluten introduction in the diet of infants at increased risk of disease. JAMA. 2005 May 18;293(19):2343-51. doi: 10.1001/jama.293.19.2343.

    PMID: 15900004BACKGROUND

  • Hoorfar J, Buschard K, Dagnaes-Hansen F. Prophylactic nutritional modification of the incidence of diabetes in autoimmune non-obese diabetic (NOD) mice. Br J Nutr. 1993 Mar;69(2):597-607. doi: 10.1079/bjn19930059.

    PMID: 8490012BACKGROUND

  • Norris JM, Barriga K, Klingensmith G, Hoffman M, Eisenbarth GS, Erlich HA, Rewers M. Timing of initial cereal exposure in infancy and risk of islet autoimmunity. JAMA. 2003 Oct 1;290(13):1713-20. doi: 10.1001/jama.290.13.1713.

    PMID: 14519705BACKGROUND

  • Funda DP, Kaas A, Bock T, Tlaskalova-Hogenova H, Buschard K. Gluten-free diet prevents diabetes in NOD mice. Diabetes Metab Res Rev. 1999 Sep-Oct;15(5):323-7. doi: 10.1002/(sici)1520-7560(199909/10)15:53.0.co;2-p.

    PMID: 10585617BACKGROUND

  • Damci T, Nuhoglu I, Devranoglu G, Osar Z, Demir M, Ilkova H. Increased intestinal permeability as a cause of fluctuating postprandial blood glucose levels in Type 1 diabetic patients. Eur J Clin Invest. 2003 May;33(5):397-401. doi: 10.1046/j.1365-2362.2003.01161.x.

    PMID: 12713453BACKGROUND

  • Meddings JB, Jarand J, Urbanski SJ, Hardin J, Gall DG. Increased gastrointestinal permeability is an early lesion in the spontaneously diabetic BB rat. Am J Physiol. 1999 Apr;276(4):G951-7. doi: 10.1152/ajpgi.1999.276.4.G951.

    PMID: 10198339BACKGROUND

  • Clemente MG, De Virgiliis S, Kang JS, Macatagney R, Musu MP, Di Pierro MR, Drago S, Congia M, Fasano A. Early effects of gliadin on enterocyte intracellular signalling involved in intestinal barrier function. Gut. 2003 Feb;52(2):218-23. doi: 10.1136/gut.52.2.218.

    PMID: 12524403BACKGROUND

  • Watts T, Berti I, Sapone A, Gerarduzzi T, Not T, Zielke R, Fasano A. Role of the intestinal tight junction modulator zonulin in the pathogenesis of type I diabetes in BB diabetic-prone rats. Proc Natl Acad Sci U S A. 2005 Feb 22;102(8):2916-21. doi: 10.1073/pnas.0500178102. Epub 2005 Feb 14.

    PMID: 15710870BACKGROUND

  • Sollid LM, Lundin KE. [Disease mechanisms in coeliac disease]. Tidsskr Nor Laegeforen. 2003 Nov 20;123(22):3230-3. Norwegian.

    PMID: 14714017BACKGROUND

  • Gronlund MM, Arvilommi H, Kero P, Lehtonen OP, Isolauri E. Importance of intestinal colonisation in the maturation of humoral immunity in early infancy: a prospective follow up study of healthy infants aged 0-6 months. Arch Dis Child Fetal Neonatal Ed. 2000 Nov;83(3):F186-92. doi: 10.1136/fn.83.3.f186.

    PMID: 11040166BACKGROUND

  • Kirjavainen PV, Arvola T, Salminen SJ, Isolauri E. Aberrant composition of gut microbiota of allergic infants: a target of bifidobacterial therapy at weaning? Gut. 2002 Jul;51(1):51-5. doi: 10.1136/gut.51.1.51.

    PMID: 12077091BACKGROUND

Related Links

MeSH Terms

Conditions

Celiac Disease

Interventions

GlutensDiet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage ProteinsDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Alessio Fasano, M.D.

    Center for Celiac Research MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pediatric Gastroenterology and Nutrition

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 9, 2009

Study Start

April 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

US(1)