FAQs

1. Pregnant women if you:

• Can read and understand written instructions in English

• Are at least 18 years old

• Planning to give birth at the University of Michigan Von Voigtlander Women’s Hospital in Ann Arbor (sometimes called Mott)

• Agree to enroll your baby into the study at birth

2. Biological fathers if you:

• Can read and understand written instructions in English

3. Siblings of the newborn if they:

• Are full biological siblings

• Agree to the study

4. Newborn babies if:

• They are born without any major complications and are at least 34 weeks gestation

• At least one parent consents for the baby

• Yes. Parents will be paid $200 for their baby's study visits which include a successful blood draw. There will be 4 study visits. 

• Parents and siblings will be paid $100 each for completing a successful blood draw one time. 

• If a child is eligible for an oral food challenge to test for food allergy, they will be paid $100 for every oral food challenge they complete.

• Parents will be paid $5 for completing a short food introduction questionnaire twice a month from when their baby is 5 months old to 12 months old. For a total of $80 for 16 questionnaires.

• Parents will be paid $20 to complete additional surveys at specified intervals throughout the study. 

• Payment will be in the form of a visa gift card or check.

An anonymous donor has generously offered a gift to the Mary H. Weiser Food Allergy Center to fund this study. This person does not have any conflicts of interest.

Yes, you must live within 50 miles of Ann Arbor and agree to come to Ann Arbor for in-person study visits

Yes, as long as your child will have a first degree relative (in this case biological mom or biological dad) with a history of atopy (food allergies, seasonal allergies, eczema, or asthma)

A. General Study Procedures

Pregnant women, the biological father, and any eligible sibling(s) consent to the study.

During pregnancy:

1.       A blood draw will be completed at a University of Michigan Blood Draw Station. 

2.       A self-administered vaginal swab will be collected. A swab kit will be given to the participants for this purpose.

3.       A stool sample will be collected using a home stool collection kit, given to participants by the study staff. 

4.       A water loss measurement device will be lightly set on the arm to collect a skin water loss sample. This will take about 5 minutes and does not hurt.

5.       Surveys asking about allergy history and other medical history will be completed electronically. Questions can be skipped if the participant is uncomfortable answering.

At birth:

1.       A small portion of the placenta and umbilical cord blood that will otherwise be discarded will be collected for the study. If applicable for infants undergoing circumcision, foreskin that would otherwise be discarded will be collected.

Within one year after the birth of the baby, biological father and siblings will complete:

1.       A blood draw will be completed a University of Michigan Blood Draw Station. 

2.       A stool sample will be collected using a home stool collection kit, given to participants by the study staff.

3.       A water loss measurement device will be lightly set on the arm to collect a skin water loss sample. This will take about 5 minutes and does not hurt.

4.       Surveys asking about allergy history and other medical history will be completed. Questions can be skipped if the participant is uncomfortable answering.

Two weeks after birth:

1.       Study staff will come to the home and collect a stool sample (swabbed from a dirty diaper) from the baby and a 1oz breastmilk sample if available.

Two months after birth:

1.       Study staff will come to the home and collect a stool sample (swabbed from a dirty diaper) from the baby and a 1oz breastmilk sample if available. 

2.       Study staff will also look at the infant’s skin for any signs of eczema.

3.       Study staff will take a home dust sample and home water sample. This will only take a few minutes.

Five months after birth:

1.       Visit to the University of Michigan’s study site at Domino’s Farms in Ann Arbor

2.       A blood sample will be taken from the baby at a University of Michigan Blood Draw Station. 

3.       A water loss measurement device will be lightly set on the baby’s arm to collect a skin water loss sample from the baby. This will take about 5 minutes and does not hurt.

4.       A 1oz breastmilk sample, if available.

5.        Food allergy testing will be completed using a skin-prick test.

6.       Surveys asking about the health of the baby and their family members will be completed by a parent or guardian.

One (1) year after birth:

1.       Visit to the University of Michigan’s study site at Domino’s Farms in Ann Arbor

7.       A blood sample will be taken from the baby at a University of Michigan Blood Draw Station. 

2.       A water loss measurement device will be lightly set on the baby’s arm to collect a skin water loss sample. This will take about 5 minutes and does not hurt.

3.       A stool sample (swabbed from a dirty diaper) from the baby and a 1oz breastmilk sample, if available. 

4.       Food allergy testing will be completed using a skin-prick test.

5.       Surveys asking about the health of the baby and their family members will be completed by a parent or guardian.

Two (2) years after birth:

1.       Visit to the University of Michigan’s study site at Domino’s Farms in Ann Arbor

2.       A blood sample will be taken from the baby at a University of Michigan Blood Draw Station.

3.       A water loss measurement device will be lightly set on the baby’s arm to collect a skin water loss sample. This will take about 5 minutes and does not hurt.

4.       Food allergy testing will be completed using a skin-prick test.

5.       Surveys asking about the health of the baby and their family members will be completed by a parent or guardian.

Three (3) years after birth:

1.       Visit to the University of Michigan’s study site at Domino’s Farms in Ann Arbor

2.       A blood sample will be taken from the baby at a University of Michigan Blood Draw Station. 

3.       A water loss measurement device will be lightly set on the baby’s arm to collect a skin water loss sample. This will take about 5 minutes and does not hurt.

4.       Food allergy testing will be completed using a skin-prick test.

5.       Surveys asking about the health of the baby and their family members will be completed by a parent or guardian.

Between 5 months and 3 years:

1.       If the baby tests positive for food allergies on either the blood or skin tests or if they experience an allergic reaction to any foods during the normal food-introduction period, the baby will be brought to the study clinic at Domino’s Farms to have further allergy testing completed. This is mandatory for participation.

a.       This testing will include “oral food challenges” and will be completed by trained study staff and will be supervised by a medical doctor specializing in allergies.

2.       If a baby does not have an allergic reaction to any foods during this time, oral food challenges will not be part of their participation.

OFC (Oral Food Challenge) procedure: The Oral Food Challenge (OFC) is the gold standard for the diagnosis of food allergy.  Not all individuals who have positive testing for food allergies in the blood or on the skin have a true food allergy.  Positive testing can happen in as many as 50% of individuals who have no food allergies. The only way to officially diagnosis a food allergy is with an OFC. OFCs will be conducted exactly according to the clinical OFC practices. Briefly, OFCs occur in the clinical research area and vital signs (height, weight, temperature, heart rate, respiratory rate, blood pressure, a finger blood oxygen meter will be used) and a review of any additional symptoms or new medications since the screening will be recorded. Then, food doses will be given in small amounts that increase in size up to a defined single serving of the food for the age/size of the participant. The OFC will proceed until a full dose is consumed without symptoms, or until a reaction occurs.  The OFC will be performed by trained nurses and with a medical doctor who specializes in allergies present.  If a reaction were to occur, the individual will be treated immediately. Most OFCs require 2-4 hours of time in the office.

Yes, we encourage non-biological parents to participate by completing surveys about the baby enrolled in the study. However, because this study is looking at how genetics and food allergy development are related, they will not have their blood drawn.

Our research office is at Domino's Farms on the North side of Ann Arbor. 

For blood draws related to M-SIBS, you will be able to use the Michigan Blood Draw Stations at East Ann Arbor or Mott Hospital