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Sponsored by: |
University of Maryland |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00819819 |
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.
Condition | Intervention |
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Celiac Disease Infant Nutrition |
Dietary Supplement: Gluten Dietary Supplement: Gluten free diet |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Timing of Gluten Intake In Infant Nutrition and Risk of Celiac Disease Autoimmunity |
Estimated Enrollment: | 1042 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Gluten containing diet: Active Comparator
Gluten added to diet at 6 months per American Academy of Pediatrics recommendations
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Dietary Supplement: 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.
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2 Gluten free diet: Active Comparator
Purified corn starch added to diet from 6-12 months
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Dietary Supplement: Gluten free diet
Purified cornstarch 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.
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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 two months Following investigations will be performed at the time of recruitment, 12 months, 18 months, 24 months, 30 months, and 36 months by taking a sample of blood (maximum 4 ml) in infants fasting form at least 4 hours: (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) sugar permeability test with lactulose/mannitol on serum (0.25 ml); (d) 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 and 18 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.
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elaine L Leonard Puppa, RN, MEd, MSN | 410-706-6810 | epuppa@peds.umaryland.edu |
Contact: Debby Kryszak, BS | 410-706-3734 | dkryszak@peds.umaryland.edu |
United States, Maryland | |
University of Maryland Baltimore | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Principal Investigator: Alessio Fasano, M. D. |
Principal Investigator: | Alessio Fasano, M.D. | Mucosal Biology Research Center |
Responsible Party: | University of Maryland Baltimore ( Alessio Fasano, M.D. ) |
Study ID Numbers: | H26146, 1R21DK078699-01A1 |
Study First Received: | January 7, 2009 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00819819 |
Health Authority: | United States: Institutional Review Board |
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes |
Celiac Disease Metabolic disorder Intestinal Diseases |