I should have checked the TRIGR web site first. Here's the rationale for the
study and the use of formula:

http://www.trigr.org/about.html

"The rationale for TRIGR began with observational studies that showed that
breastfeeding was associated with somewhat lower rates of children
developing type 1 diabetes. These studies first appeared in the mid-1980’s.
At virtually the same time, basic research began at the Hospital for Sick
Children in Toronto, Canada, focusing on the role of cow’s milk proteins in
diabetes in animals. The reason to focus on cow’s milk was motivated by the
fact that cow’s milk based infant formula is the foreign, intact, food
protein most commonly encountered first by babies. This work has further
been developed in Europe, the United States, Australia and South America.
Recently, studies have focused on hydrolyzed formulas – those in which a
chemical reaction was used to break down the proteins into smaller
components. Decreased rates of type 1 diabetes development were found in
animals weaned to hydrolyzed proteins instead of intact foreign proteins.
Some evidence is now available suggesting that a similar relationship may
exist in humans. “It appears that the immune system in young infants with
genetic diabetes risk is less mature and unable to normally handle intact
foreign food proteins. This sets up a chain reaction that can lead to
autoimmune destruction of insulin-producing cells,” said Prof. Michael
Dosch, Chair of the TRIGR Scientific Advisory Committee and co-founder of
the TRIGR effort in Toronto.

A randomized controlled trial - the standard type of research study to
determine whether a medical treatment is effective in humans - is the next
step to find out whether this work will lead to protection against type 1
diabetes. Such a trial has been developed and tested by and international
team of physicians and scientists led by Prof. Hans Åkerblom in Helsinki,
Finland. These years of development and study set the stage for the
multinational TRIGR trial, now underway on three continents.

This study is designed not to interfere with infant feeding practices,
except to emphasize and encourage breastfeeding. All mothers who participate
in TRIGR will be counseled and supported to exclusively breastfeed their
babies for at least the first six months of life in accordance with the
World Health Organization 2001 recommendation based on the benefits of
breastfeeding for this time period
(http://www.who.int/child-adolescent-health/New_Publications/NUTRITION/WHO_C
AH_01_24.pdf). However, one problem often encountered by mothers that have
type 1 diabetes themselves is that exclusive breastfeeding can not be
sustained for medical reasons.

The TRIGR trial will determine whether delayed exposure to intact food
proteins will reduce the chances of developing type 1 diabetes later in
life. All babies in the study receive the recommendation to breastfeed for
at least the first six months of life. If a mother is unable to exclusively
breastfeed before the baby is 8 months of age, her child will be randomly
assigned to one of two groups. One group of these babies will receive
breastfeeding supplements of a trial formula based on extensively hydrolyzed
protein; the other group will receive a special trial formula containing a
smaller amount of hydrolyzed protein. In hydrolyzed protein, the big protein
molecules have been split into very small fragments to provide a source of
nutritional amino acids, but the fragments are likely too small to stimulate
the immune system."

Pat W
LC

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