.png)
Infant Restore Study
A study to assess a microbiome program's impact on infant gut health and parental empowerment.
What are we trying to do?
Study summary
The goal of this study is to assess the efficacy of a microbiome analysis, education and recommendation program in improving infant gut health, reducing risk of future health conditions, and empowering parents in their children's health. Over the course of 6 months, participants in the intervention group will receive two infant gut health test reports with microbiome results, personalized recommended actions, and educational materials on the infant gut microbiome, while participants in the control group will receive these materials after the completion of the study.
Approved by Sterling IRB, IRB ID: 10947
Am I eligible to participate?
You may be eligible if you have an infant that is 0 to 3 months of age at time of enrollment.
Inclusion criteria
Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment.
Infant was delivered via Cesarean delivery (C-section).
Exclusion criteria
Infants cannot have been given probiotic supplements in their life at time of enrollment. This includes probiotic powder or supplements or formula with probiotic addition or multivitamin with probiotic addition.
Twin and multiple birth infants are not accepted in this study.
Infants must be full term or no less than 36-weeks gestation at delivery.
Infants must be residents of the United States with US postal service.
Infants cannot have the following existing health conditions:
Pre-existing gut conditions (Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) such as eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS))
Immune or auto-immune conditions (severe combined immunodeficiency (SCID), human immunodeficiency virus (HIV)), excluding eczema and rashes
Congenital conditions (cleft lip or cleft palate, congenital heart disease, cerebral palsy, fragile X syndrome, down syndrome, spina bifida, cystic fibrosis, phenylketonuria (PKU), congenital hypothyroidism (CHT), galactosaemia)
Blood disorders (sickle cell disease, thalassemia, hemophilia)
Infants are excluded if they or any of their immediate family members have received results from an at-home microbiome stool test in the past. This does not include clinical workup such as culture or pathogen testing.
How to join the study
If you are interested, please complete the survey. Interested individuals will submit their infant's age, delivery mode, probiotic usage, and email. If you and your infant qualify for the study, a clinical coordinator will meet with you virtually to enroll you in the study and sign consent forms.
I’m interestedFrequently asked questions
What is the cost and time commitment?
There is no cost to participation. You must be capable of taking two microbiome stool samples and filling out surveys online. You must also agree to receive emails. If you are selected for the intervention arm, you must also agree to attend at least 5 out of 7 consult calls, to be scheduled with our team.
What do I get for participating?
You will receive 2 microbiome stool sample kits (estimated value $398). If you are selected for our intervention arm, you will receive your full infant gut microbiome reports, including all evaluations and recommended action plan as part of the study design. If you are part of our control arm, you will still receive your full reports, however you will receive it after completion of the final survey and your participation in the study is complete. You will also receive a 25% off discount code for resample kits ($50 value) after the study’s completion.
Are there any risks to participating?
Data exposure: Seeding will collect personal identification information such as names, emails, addresses, and health information via online surveys. The risk of personal information or microbiome data being exposed is a possibility. To prevent this risk, all personal information is stored in encrypted databases with access limited to dual authentication select employees. Infant stool samples are de-identified using a kit id before being sent to partners for DNA extraction and sequencing.
Reactions and side effects
Participants in the intervention arm will receive action plans that are personalized to their microbiome results. These actions can include lifestyle, dietary, and supplemental suggestions. All suggestions are publicly available, and all recommended actions taken during this study are voluntary and at the discretion of parents and their child’s healthcare providers. It is possible that infants will experience side effects to these actions. Most common side effects to probiotics include abdominal discomfort, diarrhea, nausea, vomiting, gassiness, or bloating. To decrease risk of side effects, all probiotic, supplemental, or dietary actions should be discussed with the child’s healthcare provider. All probiotics and supplements should be taken as advised by the manufacturer.
Interested?
If you are interested, please complete the survey. Interested individuals will submit their infant's age, delivery mode, probiotic usage, and email. If you and your infant qualify for the study, a clinical coordinator will meet with you virtually to enroll you in the study and sign consent forms.
I’m interestedMedical Advisors
Rodney Dietert, PhD
Professor Emeritus of Microbiology & Immunology, Cornell University
Dr. Kim Green, MD
Associate Clinical Professor, UCSF; Pediatrician and former Chief Innovation Officer, Kaiser Permanente
Ruben Mars, PhD
Assistant Professor of Medicine, Center for Individualized Medicine Microbiome Program, Mayo Clinic, Rochester, MN
Nicole Calloway Rankins, MD, MPH
Medical Advisor; Practicing OB/GYN Hospitalist Physician, Creator and Host of The All About Pregnancy & Birth Podcast
Meghan Azad, PhD
Associate Professor of Pediatrics and Child Health at the University of Manitoba; Co-Director, Manitoba Interdisciplinary Lactation Center (MILC); Deputy Director, CHILD Cohort Study
Joel Warsh, MD
Board-Certified Pediatrician, Creator of Raising Amazing Podcast
Noel Mueller, PhD
Associate Professor of Epidemiology, Johns Hopkins University
Dr. Elisa Song, MD
Integrative Pediatrician and Pediatric Functional Medicine ExertFounder, Healthy Kids Happy Kids
Ana Santos Almeida, PhD
Instituto de Medicina Molecular Faculty of Medicine, University of Lisbon