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Microbiome Restoration
Fecal Transplant for Antibiotic-Related Gut Disruption (aFMT-babies Trial)
Phase 1
Recruiting
Led By Maria Gloria Dominguez-Bello, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate the impact of antibiotics on gut bacteria in infants and children. The study suggests that early exposure to antibiotics can disrupt the natural balance of gut bacteria, which may lead to various health
Who is the study for?
This trial is for infants who have been prescribed antibiotics, which can disrupt their gut bacteria. The study aims to help these young patients by using a treatment that involves giving back their own stored fecal matter after antibiotic use to restore the balance of good bacteria in their intestines.
What is being tested?
The intervention being studied is autologous fecal matter transplant (FMT). This means taking a sample of an infant's stool before they start antibiotics and then reintroducing it into their system afterwards, with the goal of quickly rebuilding a healthy gut microbiome.
What are the potential side effects?
Since this trial uses the child's own fecal material, side effects may be minimal compared to other interventions. However, potential risks could include discomfort during collection or administration process and possible infection if not properly handled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
safety of the autologous FMT measured via questionnaires and medical evaluations
Secondary study objectives
microbiome structure during development measured via DNA sequencing
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,911 Total Patients Enrolled
Maria Gloria Dominguez-Bello, PhDPrincipal InvestigatorRutgers Department of Biochemistry & Microbiology
1 Previous Clinical Trials