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 daily prebiotic supplementation affects functional constipation in children.
Functional constipation affects approximately 14% of children worldwide*
If your child is struggling with chronic constipation, you're not alone. Prebiotics—natural, non-digestible fibers—nurture beneficial gut bacteria, enhancing stool consistency and promoting regular bowel movements. (source: https://doi.org/10.1080/17474124.2017.1359539)
This study investigates the potential of prebiotic supplementation to alleviate chronic constipation in children by assessing its effects on stool consistency, gastrointestinal motility, and overall gut health. All participants will take either a prebiotic supplement or placebo for 90 days as well as a gut microbiome test at the beginning and end of the study.
*source: doi: 10.3748/wjg.v29.i8.1261Tran DL, Sintusek P. Functional constipation in children: What physicians should know. World J Gastroenterol 2023; 29(8): 1261-1288 [PMID: PMC10011959 DOI: 10.3748/wjg.v29.i8.1261
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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.
Am I eligible to participate?
Inclusion criteria
Infants are qualified for this study if they:
- Are 12-42 months old at the time of enrolment
- Have a diagnosis of functional constipation by their pediatrician or health care provider (according to Rome IV diagnostic criteria) and be able to provide proof of diagnosis
- Have at least two of the following symptoms at least once per week
- Fewer than 3 stools per week
- Painful or hard stools
- Very large stool
- Stool retention
- Hard stool found during abdominal or rectal exam
- Have used laxatives more than once in the past 6 months to resolve constipation
- Are at least 6 months past weaning from breastmilk or formula - 80% of diet from solids or dairy.
- Are residents of the United States with US postal service.
Exclusion criteria
- Infants cannot have the following existing health conditions:
- Metabolic and gastrointestinal diseases (such as hypothyroidism and celiac disease)
- Neuropathic diseases (such as spinal cord abnormalities and cerebral palsy)
- Intestinal nervous and muscle diseases (such as Hirschsprung disease, intestinal neuronal dysplasia, intestinal pseudo-obstruction, visceral myopathies, and visceral neuropathy)
- Abnormal abdominal muscle morphology (such as prune belly syndrome, gastroschisis, and Down syndrome)
- Connective tissue disorders (such as scleroderma, systemic lupus erythematosus, Ehlers-Danlos syndrome)
- Conditions such as heavy-metal poisoning (lead), vitamin D poisoning, botulism, and intolerance to cow’s milk protein
- Behavioral, developmental, intellectual impairment
- Infants cannot have been given probiotic supplements the last 3 months at time of enrollment. This includes probiotic powder or supplements or formula with probiotic addition or multivitamin with probiotic addition.
- Infants are excluded if they have had any drug treatment for constipation at enrollment
- Use of drugs affecting gastrointestinal motility, and children fitting criteria for irritable bowel syndrome (IBS)
Track your baby's microbiome development over time
You can learn the most about your baby’s health and protect against chronic conditions by tracking changes on their gut health over their first 1000 days.
We recommend testing at 7 days old, and every 3 months until your baby is 18 months old.
A Tiny Health subscription gets you:
- Exclusive $30 discount off each test kit
- Your kits delivered when you need them
- Enter your payment details only once
- Pay only when the tests are shipped
- Free shipping
- Skip or cancel anytime
Track your baby's microbiome development over time
You can learn the most about your baby’s health and protect against chronic conditions by tracking changes on their gut health over their first 1000 days.
We recommend testing at 7 days old, and every 3 months until your baby is 18 months old.
A Tiny Health subscription gets you:
- Exclusive $30 discount off each test kit
- Your kits delivered when you need them
- Enter your payment details only once
- Pay only when the tests are shipped
- Free shipping
- Skip or cancel anytime
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.
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.
Improve symptoms of constipation with HMO prebiotics
Begin Health offers 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?
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.
Consent to the study
The study is suitable for US residents who are 12-42 months old at the time of enrollment.
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?
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.
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
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
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.
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:
Medical Advisors
Professor Emeritus of Microbiology & Immunology, Cornell University
Ruben Mars is an Assistant Professor of Medicine at Mayo Clinic in Rochester, Minnesota.
Medical Advisor; Practicing OB/GYN Hospitalist Physician, Creator and Host of The All About Pregnancy & Birth Podcast
Associate Professor of Pediatrics and Child Health at the University of Manitoba; Co-Director, Manitoba Interdisciplinary Lactation Center (MILC); Deputy Director, CHILD Cohort Study
Associate Clinical Professor, UCSF; Pediatrician and former Chief Innovation Officer, Kaiser Permanente
Board-Certified Pediatrician, Creator of Raising Amazing Podcast
Instituto de Medicina Molecular Faculty of Medicine, University of Lisbon
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.