Infant Nutrition and Risk of Celiac Disease
| Status: | Terminated |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/23/2017 |
| Start Date: | April 2008 |
| End Date: | July 2013 |
Infant Nutrition and Risk of Celiac Disease: Proposal for an Intervention, Prospective Multicenter Study
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.
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.
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.
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.
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
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