Fecal Transplant for Antibiotic-Related Gut Disruption

(aFMT-babies Trial)

Overseen By Anna Dulencin, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Recent antibiotics, Immunological condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a child's own gut bacteria, collected before and after antibiotic use, can quickly and effectively restore gut health. The focus is on infants and toddlers who often take antibiotics for non-gut issues, disrupting their natural gut bacteria balance. Participants will have their gut bacteria preserved and reintroduced through a simple method involving their own fecal matter mixed with milk or formula, known as Autologous Fecal Transplant. Healthy infants and toddlers aged 1 month to 4 years who haven’t used antibiotics in the past three months may be eligible to join. The study aims to maintain gut health and potentially prevent future health issues linked to gut bacteria imbalances. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but children who have used antibiotics in the last 3 months cannot join the study.

What prior data suggests that this fecal transplant is safe for children?

Research has shown that autologous fecal microbiota transplantation (auto-FMT), which uses a patient's own stool, is generally safe and well-tolerated. This procedure helps restore the gut's bacterial balance after antibiotics disrupt it.

One study found that auto-FMT safely and quickly restored healthy gut bacteria, replenishing important types that antibiotics might have reduced. Another study concluded that auto-FMT is likely safe, though challenges may arise in certain settings, such as nursing homes.

While more research is needed, current evidence suggests that using one's own stool to improve gut health is a safe option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for antibiotic-related gut disruptions, which often involve probiotics or dietary changes, autologous fecal transplant uses the child's own pre-antibiotic fecal matter to restore their gut microbiome. This personalized approach ensures that the gut is re-seeded with the individual's unique microbiome composition, which can be more effective than generic probiotics. Researchers are excited because this method directly targets the microbiome imbalance caused by antibiotics and has the potential to restore gut health more precisely and quickly.

What evidence suggests that autologous fecal transplant might be an effective treatment for antibiotic-related gut disruption?

Research has shown that using one's own stool for a fecal transplant (a-FMT) can restore the natural balance of gut bacteria after antibiotic use. In this trial, participants in the intervention arm will receive an autologous fecal transplant to re-seed their gut with their own microbiome composition preserved before antibiotic use. One study found that a-FMT was more effective than probiotics in rebuilding gut bacteria. Another study showed that a-FMT helped recover the variety of gut bacteria lost due to antibiotics. This process not only balances gut bacteria but also supports the immune system. Overall, these findings suggest that a-FMT could be a promising way to reset the gut microbiome after antibiotic treatment. ^{5 6 7 8 9}

Who Is on the Research Team?

Maria Gloria Dominguez-Bello, PhD

Principal Investigator

Rutgers Department of Biochemistry & Microbiology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is between 1 month and 4 years old and healthy.

Exclusion Criteria

Documented immunological condition from the child's pediatrician

My child has not taken antibiotics in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Caregivers collect monthly fecal samples while the child is healthy and right before an antibiotic treatment.

Varies

Monthly sample collection

Antibiotic Treatment

Children receive antibiotics as prescribed by their pediatrician for a non-gastrointestinal condition.

Varies

Autologous Fecal Matter Transplant (aFMT)

One day after the last dose of antibiotics, the child receives an autologous fecal matter transplant by drinking 2 ounces of inoculum mixed with milk.

1 day

Follow-up

Caregivers continue collecting samples once a week for a month followed by once a month for five months to monitor microbiome recovery.

6 months

Weekly sample collection for 1 month, then monthly for 5 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Fecal Transplant

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 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: Control Active Control 1 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.

Autologous Fecal Transplant is already approved in United States, European Union for the following indications:

Approved in United States as Fecal Microbiota Transplantation for:

• Recurrent Clostridioides difficile (C. diff) infections

Approved in European Union as Fecal Microbiota Transplantation for:

• Recurrent Clostridioides difficile (C. diff) infections

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Fecal microbial transplantation (FMT) is an effective treatment for recurrent Clostridium difficile colitis, with various delivery methods such as oral ingestion, colonoscopy, and enemas tailored to patient needs.

Careful selection of donors and patients is essential to ensure safety and efficacy, as FMT is being explored for potential treatment of other conditions beyond just C. difficile infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Aspects of Fecal Microbial Transplantation (FMT). Bhutiani, N., Schucht, JE., Miller, KR., et al.[2018]

Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.

Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? Park, SY., Seo, GS.[2021]

Fecal microbiota transplantation (FMT) is highly effective for treating Clostridium difficile infection (CDI), with a 90% resolution of diarrhea reported in 867 patients across 33 studies, and a 94% resolution after repeated FMT in a randomized controlled trial with 16 participants.

FMT shows promise in treating ulcerative colitis, with remission rates varying from 0% to 68% in 106 patients, while its efficacy in Crohn's disease, chronic constipation, pouchitis, and irritable bowel syndrome remains inconclusive due to limited data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. Rossen, NG., MacDonald, JK., de Vries, EM., et al.[2022]

Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridioides difficile infections, highlighting its importance in clinical practice.

The selection of fecal microbiota donors is crucial for ensuring the safety of recipients, prompting the establishment of protocols and recommendations by a multidisciplinary group in Cataluña to minimize risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for stool donor selection for fecal microbiota transplant. Consensus document endorsed by the Catalan Society of Digestology, Catalan Society of Infectious diseases and Clinical microbiology and the GEMBIOTA group from Spanish Society of Infectious Diseases and Clinical Microbiology. Aira, A., Arajol, C., Casals-Pascual, C., et al.[2021]

Fecal microbiota transplantation (FMT) is a cost-effective treatment for recurrent Clostridium difficile infection (rCDI), with all economic evaluations showing it to be more cost-effective than other standard treatments at a threshold of ≤$50,000 per quality-adjusted life year (QALY).

The systematic review included 9 high-quality economic evaluations, primarily focusing on rCDI and inflammatory bowel disease (IBD), indicating that while FMT is effective for rCDI, further studies are needed to explore its economic impact for other conditions like IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of economic evaluation in fecal microbiota transplantation. Stalder, T., Kapel, N., Diaz, S., et al.[2021]

Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridioides difficile infections, highlighting its importance in clinical practice.

The selection of fecal microbiota donors is crucial for ensuring the safety of recipients, prompting the establishment of protocols and recommendations by a multidisciplinary group in Cataluña to minimize risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for stool donor selection for fecal microbiota transplant. Consensus document endorsed by the Catalan Society of Digestology, Catalan Society of Infectious diseases and Clinical Microbiology and the GEMBIOTA group from Spanish Society of Infectious Diseases and Clinical Microbiology. Aira, A., Arajol, C., Casals-Pascual, C., et al.[2022]

Fecal microbiota transplantation (FMT) has a reported adverse event (AE) rate of 39.3%, primarily involving mild and self-limiting issues like abdominal pain and diarrhea, based on a meta-analysis of 9 high-quality studies involving 756 FMTs.

Serious adverse events (SAE) were relatively rare at 5.3%, with the most common being Clostridium difficile infection, indicating that while FMT is generally safe, monitoring and standardized reporting are essential for understanding its long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. Michailidis, L., Currier, AC., Le, M., et al.[2022]

Fecal microbiota transplantation (FMT) using targeted colonic release capsules (FMTcr) showed a slightly higher clinical cure rate for recurrent Clostridium difficile infection (rCDI) at 80.6% compared to 75% for gastric release capsules (FMTgr), although the difference was not statistically significant.

Both FMT formulations were found to be safe with no serious adverse events, but FMTcr was more effective in increasing gut microbial diversity, suggesting better microbial engraftment patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose. Allegretti, JR., Fischer, M., Sagi, SV., et al.[2020]

Fecal microbiota transplantation (FMT) was performed on an 87-year-old male with recurrent cholangitis and multidrug-resistant (MDR) bacteria, showing safety and no complications across three procedures.

After FMT, there was a notable decrease in hospital admissions and a change in the microbial resistance profile of bacteria in blood cultures, suggesting that FMT may effectively manipulate gut microbiota and reduce MDR bacteremias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplant in a Patient Infected with Multidrug-Resistant Bacteria: A Case Report. Gouveia, C., Palos, C., Pereira, P., et al.[2022]

Fecal microbiota transplantation (FMT) has proven to be highly effective in treating recurrent and refractory Clostridioides difficile infections (CDI), leading to a surge in research on gut microbiota therapies.

The future of microbiome-based treatments is expected to focus on developing oral formulations with known ingredients, clear mechanisms of action, and strong safety profiles, expanding the potential applications of FMT beyond CDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert opinion on fecal microbiota transplantation for the treatment of Clostridioides difficile infection and beyond. Kumar, V., Fischer, M.[2020]

Autologous fecal microbiota transplantation (a-FMT) uses a person's own feces collected during a healthy state to restore gut microbiota, potentially offering a safer alternative to heterologous fecal microbiota transplantation (h-FMT), which carries risks of infectious exposure from donor stool.

While h-FMT has shown high cure rates (up to 90%) for recurrent Clostridioides difficile infection, its effectiveness for inflammatory bowel disease (IBD) is variable, with response rates between 24% and 50%, highlighting the complexity of IBD as a microbiome-driven disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous fecal microbiota transplantation for the treatment of inflammatory bowel disease. Basson, AR., Zhou, Y., Seo, B., et al.[2021]

Capsulized autologous faecal microbiota transplantation (FMT) was found to be safe and well tolerated in a study of 24 healthy volunteers, with no serious side effects reported during the treatment.

While both the FMT and placebo groups showed improvements in general and intestinal health after antibiotic treatment, there was no significant difference in the time it took for participants to normalize their intestinal habits, indicating that FMT did not provide additional benefits over placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. Stefansson, M., Bladh, O., Flink, O., et al.[2023]

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