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Restoration of Antibiotics Related Infant Microbiota Perturbations by Autologous Fecal Transplant

Rutgers, The State University of New Jersey · NCT06609980

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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
Restoration of Antibiotics Related Infant Microbiota Perturbations… (NCT06609980) | Bored Studies