We're launching a study to observe the impact of a prebiotics on the infant gut and constipation

Your participation could help us explore how human milk oligosaccharides (HMOs) in the supplement affect gut health. In partnership with Begin Health, we intend to publish our findings when the study concludes.

Recruitment starts March 2025

For babies ages 1-3 years old (see criteria)

Location: United States
By Kimberley Sukhum, PhD
a box, a mobile phone and part of an envelope for a gut testing application

Constipation in children is very common, with a reported frequency of up to 30%

Most children with chronic constipation are caught in a vicious cycle The cycle can start at any point and deepen its roots with each revolution.

Human Milk Oligosaccharides (HMOs) are known to selectively promote the growth of beneficial bacteria like Bifidobacterium in infants, establishing an optimal gut microbiome composition. This can contribute to the development of a robust immune system and improve symptoms of constipation. The goal of this study is to assess the efficacy of HMOs and prebiotic supplements on modulating the infant gut microbiome. All participants will take either an HMO supplement or a placebo once daily for 30 days. Each participant will also take a gut microbiome test at the beginning and end of the study.

Help to advance research on baby prebiotic supplements

Help to advance research on baby prebiotic supplements

Get the valuable insights of gut microbiome testing and discover the connection between prebiotic supplements and gut health. Help us better understand prebiotic supplements and their impact on the gut microbiome.

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Am I eligible to participate?

Inclusion criteria

  • Infants are qualified for this study if they 1-3 years old at the time of enrolment
  • Participants must have < 2 bowel movements per week for a minimum of one month at the time of enrolment with a stool consistency that is hard, dry and pellet-like or with cracks in the surface.
  • Participants must be residents of the United States with US postal service.

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.
  • 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.
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How to join the study

If you are interested, please complete the survey. If you qualify for the study, a clinical coordinator will meet with you virtually to enrol you in the study and sign consent forms.

About Tiny Health

Tiny Health was created for mom and baby

Tiny Health offers at-home gut tests for the whole family. We focus on a baby’s first 1,000 days to address imbalances that may cause chronic conditions such as allergies. Processed in a CLIA-certified lab and using comprehensive shotgun metagenomics sequencing, Tiny Health gives parents personalized insights and evidence-based recommendations to improve a baby’s lifelong health.

Tiny Health’s mission is to improve health outcomes of future generations through evidence-based insights.

About Begin Health

Improve symptoms of constipation with HMO prebiotics

Begin Health is the pioneer in the kids' health and wellness category, offering science-backed, microbiome-focused solutions that support healthy kid development from day one. Our mission is to lead a new generation of preventive health, empowering parents with simple, effective, and targeted nutrition that nurture kids’ foundational wellness through digestive health.

How does the Research Edition work?

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Apply for the study

Complete the qualification survey via the button on this page to see if you qualify.

Interested individuals will submit their details including age, probiotic usage, and review the checklist against any health conditions via email. If you qualify for the study, a clinical coordinator will meet with you virtually to enroll you in the study and sign consent forms.

Both gut samples can be taken at home by using our swab method. Samples will be mailed in using a prepaid envelope provided with the kit.

You will fill out health history and exit surveys upon sampling.

Processed in a CLIA-certified lab and using proprietary technology, Tiny Health’s gut health test provides strain-level precision and a complete list of all microbes in the vaginal and gut microbiome including bacteria, fungi, virus, parasites, and archaea. Results will take 4-5 weeks to arrive.

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Consent to the study

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Receive gut test results at the completion of the study

Every report includes a personalized expert note that is reviewed by a team of microbiome experts.

Tiny Health also provides actionable, and evidence-based recommendations to parents to help them learn about their child's gut health and course-correct and gut imbalances.

The microbiome result report and action plan are a part of the regular Tiny Health Gut Test product and not associated with the research study.

You will be eligible to receive $100 in compensation at the completion of the study and all required surveys.

How do we look at the microbiome?

Highest resolution analysis

High resolution analysis

We use shotgun metagenomics, a technology used in microbiome research. Make informed decisions with a comprehensive list of microbes found in your sample.

Breakthrough insights

Functional insights

Through functional profiling, we tell you what microbes are present, how much of them are there, and what they’re actually doing.

Targeted suggestions

Targeted suggestions

Get actionable advice tailored to your age and unique test results. Our at-home tests empower you with strain-level detail and precision science.

Your privacy comes first

Your privacy comes first

We are dedicated to safeguarding your personal information at every turn and we will never sell your personal information.  Your data is encrypted with high security standards to ensure complete confidentiality.

100% CLIA compliant lab

CLIA & CAP certified lab

Your samples are processed at a U.S. clinical-grade lab to ensure the accuracy, reliability, and timeliness of test results.

Meet our supporters:

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Medical Advisors

Rodney Dietert, PhD
Scientific Advisor

Professor Emeritus of Microbiology & Immunology, Cornell University

Ruben Mars, PhD
Founding Advisor

Ruben Mars is an Assistant Professor of Medicine at Mayo Clinic in Rochester, Minnesota.

Nicole Calloway Rankins, MD, MPH
Medical Advisor

Medical Advisor; Practicing OB/GYN Hospitalist Physician, Creator and Host of The All About Pregnancy & Birth Podcast

Meghan Azad, PhD
Scientific Advisor

Associate Professor of Pediatrics and Child Health at the University of Manitoba; Co-Director, Manitoba Interdisciplinary Lactation Center (MILC); Deputy Director, CHILD Cohort Study

Dr. Kim Green, MD
Medical Advisor

Associate Clinical Professor, UCSF; Pediatrician and former Chief Innovation Officer, Kaiser Permanente

Joel Warsh, MD
Medical Advisor

Board-Certified Pediatrician, Creator of Raising Amazing Podcast

Ana Santos Almeida, PhD
Scientific Advisor

Instituto de Medicina Molecular Faculty of Medicine, University of Lisbon

Noel Mueller, PhD
Scientific Advisor

Associate Professor of Epidemiology, Johns Hopkins University

Interested? Join this study

If you are interested, please complete the survey. Qualified individuals will be contacted by the study coordinator to provide consent and enroll in the study.

Frequently Asked Questions

There is no cost to participation. You must be capable of taking two microbiome stool samples and filling out two surveys online. Collecting a microbiome sample can be done on your own time, at home, and should take a few minutes. Each of the surveys can take anywhere between 5-15 minutes to complete, depending on the complexity of your answers. The total duration of the study is meant to conclude after taking the supplement for 30 days and completing your second sample and exit survey.

You will receive $100 in compensation at the end of the study when you have fulfilled all study responsibilities to include mailing two microbiome samples back to our lab and completing both surveys. All study participants will receive their full adult gut microbiome reports, including all evaluations and recommended action plan, approximately 4-6 weeks after the study is complete.

Data exposure: Tiny Health 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. Stool samples are de-identified using a kit id before being sent to partners for DNA extraction and sequencing.