Microbiota Transplantation for Peanut Allergy

Recruiting in Palo Alto (17 mi)

Overseen by Rima Rachid, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Rima Rachid

Must not be taking: Immunosuppressants, Omalizumab, Dupilumab, Corticosteroids

Disqualifiers: Severe anaphylaxis, Chronic infections, GI conditions, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a phase II randomized double-blind placebo-controlled trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in peanut allergic patients. In this research the investigators would like to learn more about ways to treat peanut allergies. The primary objective is to evaluate whether MTT with antibiotic pretreatment can increase the threshold of peanut reactivity during a double-blind placebo-controlled food challenge from \<=100 mg peanut protein to 300 mg after 28 days of MTT /placebo therapy and 4 months post therapy initiation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic systemic immunosuppressive therapies or have received certain allergy treatments recently, you may not be eligible to participate.

What data supports the effectiveness of the treatment for peanut allergy?

Research shows that fecal microbiota transplantation (FMT) is effective in treating recurrent Clostridium difficile infections and is being explored for other conditions, suggesting potential for broader applications. Encapsulated FMT has been found to be as effective as other delivery methods, indicating its promise as a treatment option. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) generally safe for humans?

Fecal microbiota transplantation (FMT) has been studied for various conditions, and while it shows promise, there are still concerns about adverse events (unwanted side effects). Safety measures like donor screening and careful processing are important to minimize risks. ^{1 2 6 7 8}

How does the treatment Microbiota Transplantation for Peanut Allergy differ from other treatments for this condition?

Microbiota Transplantation for Peanut Allergy is unique because it involves transferring beneficial bacteria from a healthy donor to the patient, potentially altering the gut microbiome to help manage peanut allergies. This approach is different from traditional oral immunotherapy, which focuses on gradually increasing exposure to the allergen itself. ^{9 10 11 12 13}

Research Team

Rima Rachid, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for people with a confirmed peanut allergy who react to small amounts of peanut protein. They must be able to swallow capsules, agree to birth control if applicable, and not have certain chronic illnesses or recent treatments that affect the immune system. Pregnant women and those not using contraception are excluded.

Inclusion Criteria

For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1>=80% of predicted

I am willing to be contacted by phone or email for follow-up.

Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL guidelines

Exclusion Criteria

I am a sexually active woman not using birth control.

Patients who have received peanut oral immunotherapy within the past 6 months

I am on long-term medication to suppress my immune system.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antibiotic Pretreatment

Participants receive oral antibiotics or placebo for 7 days to modulate gastrointestinal microbiota

1 week

1 visit (in-person)

MTT/Placebo Treatment

Participants receive MTT or placebo capsules under medical supervision, followed by daily administration for 27 days

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including DBPCFC and gut microbiota analysis

6 months

3 visits (in-person)

Treatment Details

Interventions

• Antibiotic (Antibiotic)
• Oral Encapsulated Microbiota Transplantation Therapy (Microbial Transplantation Therapy)

Trial Overview The study tests if fecal microbial transplantation (MTT) therapy with prior antibiotic treatment can help increase tolerance to peanuts in allergic patients. Participants will either receive MTT or placebo capsules and their reaction threshold will be tested before and after the treatment period.

Participant Groups

Group I: antibiotic / MTT Experimental Treatment 2 Interventions

Study subjects randomized to the experimental arm will receive oral antibiotics for 7 days as a way to modulate the composition of the gastrointestinal microbiota. Upon completion of oral antibiotics, subjects randomized to the experimental arm will be administeredf MTT under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take MTT capsules daily for 27 days.

Group II: placebo / placebo Active Control 2 Interventions

Study subjects randomized to the placebo arm will receive oral placebo capsules instead of oral antibiotics, for 7 days, at the same frequency and capsule amount per dose. Upon completion of 7 days of placebo (matching the antibiotics given in the experimental arm), subjects randomized to the placebo arm will be administered capsules of placebo (matching the MTT capsules given in the experimental arm) under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take placebo capsules daily for 27 days.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Children's Hospital Boston, MA

Who Is Running the Clinical Trial?

Rima Rachid

Lead Sponsor

Trials

2

Patients Recruited

40+

University of Minnesota

Collaborator

Trials

1459

Patients Recruited

1,623,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. Crothers, JW., Chu, ND., Nguyen, LTT., et al.[2022]

Fecal microbiota transplantation (FMT) has a total adverse event (AE) incidence rate of 28.5%, with abdominal discomfort being the most common AE reported in 19 studies, highlighting the need for careful monitoring during the procedure.

Serious adverse events (SAEs) occurred in 9.2% of patients, with a notable incidence of death (3.5%) and infections (2.5%), indicating that while FMT can be beneficial, it carries significant risks that require further investigation through high-quality randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review: Adverse Events of Fecal Microbiota Transplantation. Wang, S., Xu, M., Wang, W., et al.[2023]

Encapsulated faecal microbiota transplantation (FMT) is a highly effective and safe treatment for recurrent Clostridioides difficile infection (rCDI), achieving cure rates of 85% after a single course and 93% after multiple courses, based on a systematic review of 35 studies involving 960 patients.

The efficacy of encapsulated FMT for rCDI remains consistent despite variations in treatment protocols, donor screening, and capsule preparation, indicating that this method is as effective as traditional FMT delivery routes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: encapsulated faecal microbiota transplantation - evidence for clinical efficacy. Cold, F., Baunwall, SMD., Dahlerup, JF., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. Aroniadis, OC., Brandt, LJ.[2022]

In a pilot study involving nine patients with collagenous colitis, fecal microbiota transfer (FMT) showed some improvement in symptoms, particularly in reducing diarrhea and enhancing quality of life, although it did not significantly reduce the number of watery stools overall.

FMT was safe, with no serious adverse events reported, and it appeared to activate the mucosal immune system, as indicated by an increase in lamina propria lymphocytes, suggesting potential benefits for a specific subset of patients with collagenous colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faecal microbiota transfer in patients with microscopic colitis - a pilot study in collagenous colitis. Holster, S., Rode, J., Bohr, J., et al.[2021]

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]

Fecal microbiota transplantation (FMT) is being explored as a treatment for various health conditions, highlighting its potential therapeutic benefits.

The FDA is focused on ensuring the safety of FMT products through rigorous donor screening and manufacturing processes, which is crucial for conducting safe clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory Considerations for Fecal Microbiota Transplantation Products. Carlson, PE.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation: establishment of a clinical application framework. Jørgensen, SMD., Hansen, MM., Erikstrup, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights into Microbiome and Metabolic Signatures of Children Undergoing Peanut Oral Immunotherapy. Blackman, AC., Thapa, S., Venkatachalam, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol of a multicentre, randomised, controlled trial evaluating the effectiveness of probiotic and peanut oral immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with oral immunotherapy (OIT) alone and with placebo (the PPOIT-003 study). Chebar Lozinsky, A., Loke, P., Orsini, F., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanut Oral Immunotherapy: a Current Perspective. Patrawala, M., Shih, J., Lee, G., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial. Loke, P., Orsini, F., Lozinsky, AC., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral immunotherapy for peanut allergy: The pro argument. Chinthrajah, RS., Cao, S., Dunham, T., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: encapsulated faecal microbiota transplantation - evidence for clinical efficacy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Faecal microbiota transfer in patients with microscopic colitis - a pilot study in collagenous colitis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Regulatory Considerations for Fecal Microbiota Transplantation Products. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation: establishment of a clinical application framework. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Insights into Microbiome and Metabolic Signatures of Children Undergoing Peanut Oral Immunotherapy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Study protocol of a multicentre, randomised, controlled trial evaluating the effectiveness of probiotic and peanut oral immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with oral immunotherapy (OIT) alone and with placebo (the PPOIT-003 study). [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Peanut Oral Immunotherapy: a Current Perspective. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Oral immunotherapy for peanut allergy: The pro argument. [2020]