Restoration of Antibiotics Related Infant Microbiota Perturbations by Autologous Fecal Transplant
Rutgers, The State University of New Jersey · NCT06609980
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 1 mo–4 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- August 1, 2024
- Record last updated
- May 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Antibiotics are lifesaving therapeutic drugs which have been used by adults, children, and infants alike for decades. There is an increase in global use of antibiotics over the course of lifetime and earlier in lifetime, with some countries recording as high as 12 courses a year in children younger than two. While antibiotics are successful in eradicating many pathogenic bacteria, research has demonstrated significant effect on beneficial gut microbiota, including long-lasting shift in the dynamics, composition, richness, and maturity of the intestinal flora. Microbiota alterations during early life, including through antibiotics use as well as birth via C-section, constitute a developmental perturbation, which increases the risk of modern diseases of immune and metabolic dysfunction. Strong epidemiological evidence suggests associations between early stressors of the microbiota and a number of common diseases, such as obesity, asthma, allergies, celiac disease, and Type 1 Diabetes. Furthermore, excess antibiotic exposure is associated with the development of neurological and psychiatric disorders. Currently, no strategies exist to restore the microbiome other than reliance on spontaneous repair mechanism, which often takes months in a healthy individual barring further antibiotic exposure. Contrary to popular belief, ingestion of probiotics, particularly after antibiotics, has been demonstrated to slow down the repair as it introduces an exogenous and massive amounts of only a few types of bacterial strains into a finely-tuned ecosystem of hundreds of different strains.
It is hypothesized that by preserving the child's microbiome prior to antibiotic therapy and reintroducing it afterwards through an autologous fecal matter transplant (FMT) will assist in a quick, effective, and host-specific microbiome recolonization to the levels and patterns to those prior to antibiotics. This would in turn reduce the overall loss of microbiome diversity over the child's lifespan, essentially providing a 'reset' option to the child's most unadulterated version of microbiome. This approach utilizes delivering the sample by mixing it in maternal milk or formula and feeding it to the child through a bottle, which can be performed anywhere without any discomfort for the child.
Being studied: autologous fecal matter transplant
Conditions: Antibiotic Treatment
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- healthy infants and toddlers 1 month to 4 years of age (regardless of birth mode, sex, or diet (breastmilk, formula, solids, etc.)
Exclusion Criteria
- Child's antibiotic use within 3 months before inclusion in the study
- Documented immunological condition from the child's pediatrician
Recruiting US locations
Rutgers Department of Biochemistry & Microbiology
New Brunswick, NJ 08901
Site contact: Maria Gloria Dominguez-Bello, PhD · 848-932-5648 · md1360@sebs.rutgers.edu
Study contacts (from the official record)
- Maria Gloria Dominguez-Bello, PhD · 848-932-5648 · md1360@sebs.rutgers.edu
- Anna Dulencin, PhD · (848) 932-8309 · anna.dulencin@eagleton.rutgers.edu
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