Overview

This trial is active, not recruiting.

Conditions celiac disease, infant nutrition
Treatments gluten, gluten free diet
Sponsor Massachusetts General Hospital
Start date April 2008
End date March 2017
Trial size 1042 participants
Trial identifier NCT00819819, 1R21DK078699-01A1, 2013P000287

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator)
Primary purpose prevention
Arm
(Active Comparator)
Gluten added to diet at 6 months per American Academy of Pediatrics recommendations
gluten
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.
(Active Comparator)
Non gluten containing food starch added to diet from 6-12 months
gluten free diet
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.

Primary Outcomes

Measure
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
time frame: 5 years

Eligibility Criteria

Male or female participants up to 6 months old.

Inclusion Criteria: - 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) Exclusion Criteria: - Infants that have gluten introduced in their diet before 5-6 months of age - Infants older than 6 months of age

Additional Information

Official title Infant Nutrition and Risk of Celiac Disease: Proposal for an Intervention, Prospective Multicenter Study
Principal investigator Alessio Fasano, M.D.
Description From weaning to age 12 months the clinical data, the adherence to the dietary protocol and the amount of intervention baby-food ingested will be checked every month. Following investigations will be performed at the time of recruitment, at time of weaning and at 12, 18, 24, 30,36, 42, 48, 54 and 60 months by taking a sample of blood (maximum 4 ml) from infants (a) quick test for IgA anti-tTG abs determination (few drops); (b) conventional ELISA for serum IgA and IgG anti-tTG determination (0.4 ml);(c) serum zonulin determination (0.1 ml); (e) serum sample for T1D-related autoantibodies (0.25 ml); (f) serum sample to be stocked in the sera bank (0.25 ml); (g) whole blood sample in EDTA for validation of the quick tests (0.5 ml). All the sera samples will be frozen, stored at -20 °C and sent (boxed in dry ice) in blocks to the centre responsible for the determinations every 2 months. Cases positive for the quick-test for anti-tTG the serum sample will be frozen and immediately shipped for confirmatory determination. If infants develop symptoms during the intervention period (6 to 12 months) the group to which infant belongs will be decoded. Infants belonging to group A (on a gluten-containing diet) presenting symptoms suggestive of CD will undergo a complete diagnostic work-up for CD. These events will be reported in a form. After age 1 year, infants developing symptoms suggestive of active CD (chronic diarrhea, failure to thrive, etc) in-between the scheduled visits will undergo a supplementary serological investigation. A small intestinal biopsy will be recommended in cases showing either serum anti-tTG abs higher than the cut-off or IgG-AGA higher than cut-off in infants with selective IgA deficiency. (Standard medical care and not part of research). The evolution of the composition of the intestinal microbiota will be evaluated in both groups at 7d, 30d, 4-6 months (prior to weaning), 12,18,24,30,36, 42, 48, 54 and 60 months. The bacterial composition of stool will also be analyzed in a sub-sample of children developing active CD and in non-CD controls. All patients who develop CD will continue in the study. Definitions: Active CD: Children showing positive serology and signs of immune-mediated damage of the small intestinal mucosa on biopsy (ranging from isolated increase of intraepithelial lymphocytes to villous atrophy with crypt hypertrophy.) CD serological autoimmunity positive: Children positive for IgA anti-tTG abs on two consecutive occasions. Disruption of the small intestinal barrier: Children with an increased ratio of serum lactulose/mannitol with or without increased levels of serum zonulin.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.