Improving gut health in infants with a special formula
A Randomized, Controlled Trial of Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula
This study is testing a new infant formula with probiotics to see if it can help improve gut health and increase bowel movements in newborns compared to regular formula and breastfeeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Heilongjiang Feihe Dairy Co. Ltd. Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06159088 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an investigational infant formula containing probiotics and hydrolyzed whey protein in enhancing gut health, specifically focusing on the frequency of bowel movements in newborns. A total of 240 participants will be randomly assigned to one of three groups: the investigational formula, a control formula, or breastfeeding, and monitored over a 12-month period. The study will involve up to six site visits for each participant to collect clinical data and questionnaires, with the primary outcome being the frequency of bowel movements. The trial seeks to determine if the investigational formula leads to significantly better outcomes compared to the other feeding methods.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants aged 28 days or younger who are exclusively formula-fed and meet specific health criteria.
Not a fit: Patients with underlying metabolic or chronic diseases, congenital malformations, or feeding difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gut health and bowel movement frequency in infants, potentially reducing gastrointestinal issues.
How similar studies have performed: Other studies have shown promising results with probiotics in infant formulas, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborn baby, study entry before weaning (within 28 days of birth) * Exclusively formula for at least 3 days fed prior to onset of study period. * Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age). * Birth weight of 2500g (5 lbs. 8 oz.) or more. * Signed informed consent obtained for infant's participation in the study. * Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study. Exclusion Criteria: * History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant. * Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion). * Evidence of growth problems or concern for growth. * Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth. * Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury. * Use of probiotics/prebiotics before and during the study.
Where this trial is running
Hangzhou, Zhejiang
- Kaitai Scientific Lab — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Charlie Zhang, MD — SPRIM Medical
- Study coordinator: Charlie Zhang, MD
- Email: charlie.zhang@sprimmedical.com
- Phone: +8613901981272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.