Restoration of Antibiotics Related Infant Microbiota Perturbations by Autologous Fecal Transplant

NCT06609980 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro2022001766
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antibiotic Treatment

Keywords

FMT; autologous; children

Outcome Measures

Primary Outcomes (1)

• safety of the autologous FMT measured via questionnaires and medical evaluations

  Endpoints: Safety, defined as no/minimal serious adverse effects

  6 months

Secondary Outcomes (1)

• microbiome structure during development measured via DNA sequencing

  6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Caregivers of the participants in the intervention arm will collect monthly fecal samples while the child is healthy and right before an antibiotic treatment which has been prescribed by the pediatrician for a non-gastrointestinal condition. One day after the last dose of antibiotics, the caregiver will collect another fecal sample and then the child will orally drink 2 ounces of the autologous fecal matter transplant inoculum prepared by the research team by mixing the child's own most recent sample prior to falling ill and mixed with milk. The caregivers then continue collecting samples once a week for a month followed by once a month for five months.

Drug: autologous fecal matter transplant

Control

NO INTERVENTION

Participants do not partake in the autologous fecal matter transplant that will be used to re-seed the child's gut with his or her own personalized microbiome composition which was preserved prior to antibiotics use.

Interventions

autologous fecal matter transplant DRUG

Autologous fecal matter transplant will be used to re-seed the child's gut with his or her own personalized microbiome composition which was preserved prior to antibiotics use.

Intervention Arm

Eligibility Criteria

• Age: 1 Month - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy infants and toddlers 1 month to 4 years of age (regardless of birth mode, sex, or diet (breastmilk, formula, solids, etc.)

You may not qualify if:

• Documented immunological condition from the child's pediatrician

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Department of Biochemistry & Microbiology

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (28)

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Study Officials

• Maria Gloria Dominguez-Bello, PhD

  Rutgers Department of Biochemistry & Microbiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Gloria Dominguez-Bello, PhD

CONTACT

848-932-5648; md1360@sebs.rutgers.edu

Anna Dulencin, PhD

CONTACT

(848) 932-8309; anna.dulencin@eagleton.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis will be done on de-identified samples so the outcomes assessor will be unaware
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: September 24, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At the time publication of results, DNA sequences will be published as requested by the Journals, in a sequences database (such as ENA, SRA, GenBank, DDBJ).
• Access Criteria: Determined by the biological database of computerized ("digital") nucleic acid sequences.

Locations

US (1)