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Microbial Transplantation Therapy

Microbiota Transplantation for Peanut Allergy

Q: Are senior citizens being accepted as participants in this research experiment?

This research trial seeks participants of age 12 to 17 years old.

Q: Is there still an opportunity to volunteer for this experimentation?

As noted on clinicaltrials.gov, this particular medical trial is not currently open for recruitment; the study was initially posted on February 15th 2023 and last updated on January 23rd of that same year. Nevertheless, there are 260 other trials actively looking for participants at present.

Q: Are there any concerns regarding the use of antibiotic / MTT with regards to patient safety?

With prior evidence of safety but none for efficacy, the risk level associated with antibiotic/MTT was rated as a 2.

Q: Who satisfies the criteria for inclusion in this research project?

This medical trial intends to recruit 24 participants between 12 and 17 years of age, who have been diagnosed with a <a href="https://www.withpower.com/clinical-trials/peanut-allergy">peanut allergy</a>. In addition to being in the specified age range, potential patients must possess certain characteristics: they should present dose-limiting symptoms on ingestion of 1 mg, 3 mg, 10 mg, 30 mg or 100mg of peanut protein during an oral challenge (as per Practical Issues in Allergology protocols); demonstrate positive results for skin prick tests (with readings above 3mm) and/or positve levels for specific IgE antibodies (>0.35kU/L), etc. Moreover, female candidates will be

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

~3070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER

1,380 Previous Clinical Trials

1,588,721 Total Patients Enrolled

Rima RachidLead Sponsor

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Oral Encapsulated Microbiota Transplantation Therapy (Microbial Transplantation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05695261 — Phase 2

Peanut Allergy Research Study Groups: placebo / placebo, antibiotic / MTT

Peanut Allergy Clinical Trial 2023: Oral Encapsulated Microbiota Transplantation Therapy Highlights & Side Effects. Trial Name: NCT05695261 — Phase 2

Oral Encapsulated Microbiota Transplantation Therapy (Microbial Transplantation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695261 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens being accepted as participants in this research experiment?

"This research trial seeks participants of age 12 to 17 years old."

Answered by AI

Is there still an opportunity to volunteer for this experimentation?

"As noted on clinicaltrials.gov, this particular medical trial is not currently open for recruitment; the study was initially posted on February 15th 2023 and last updated on January 23rd of that same year. Nevertheless, there are 260 other trials actively looking for participants at present."

Answered by AI

Are there any concerns regarding the use of antibiotic / MTT with regards to patient safety?

"With prior evidence of safety but none for efficacy, the risk level associated with antibiotic/MTT was rated as a 2."

Answered by AI

Who satisfies the criteria for inclusion in this research project?

"This medical trial intends to recruit 24 participants between 12 and 17 years of age, who have been diagnosed with a peanut allergy. In addition to being in the specified age range, potential patients must possess certain characteristics: they should present dose-limiting symptoms on ingestion of 1 mg, 3 mg, 10 mg, 30 mg or 100mg of peanut protein during an oral challenge (as per Practical Issues in Allergology protocols); demonstrate positive results for skin prick tests (with readings above 3mm) and/or positve levels for specific IgE antibodies (>0.35kU/L), etc. Moreover, female candidates will be"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients

Rima Rachid 2023. "Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05695261.

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