Microbiota Transplantation for Peanut Allergy

Phase 2

Recruiting

Research Sponsored by Rima Rachid

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 8 months

Summary

This trial is researching ways to treat peanut allergies, to see if oral MTT with pretreatment can increase the threshold of peanut reactivity.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive discomfort due to antibiotics or MTT, allergic reactions during the food challenge test, and possible unknown risks from altering gut bacteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein)

Secondary study objectives

Adverse Events

Changes in Biomarkers

Changes in Gut Microbial Composition

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: antibiotic / MTTExperimental Treatment2 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 / placeboActive Control2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antibiotic

2008

Completed Phase 4

~6180

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