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Microbiome Therapy

Active for Intestinal Microbiome

Phase 1

Recruiting

Led By J. David Spence, M.D.

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe atherosclerosis, with total plaque area in the top quartile (>119 mm2), not explained by traditional risk factors in linear regression (residual score >= 2)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 12 months

Awards & highlights

Study Summary

"This trial aims to treat patients with unexplained severe atherosclerosis by giving them fecal transplants from patients with a Protected phenotype. The goal is to see how this affects the intestinal microbiome and

Who is the study for?

This trial is for people with severe atherosclerosis, where plaque buildup in arteries isn't due to usual risk factors. Participants should have a high amount of plaque (top 25%) and not fit the typical profile for heart disease as assessed by doctors.Check my eligibility

What is being tested?

The study tests if fecal microbial transplants from individuals resistant to artery plaque can improve gut bacteria in those with unexplained atherosclerosis, potentially lowering harmful metabolites like TMAO.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort, changes in bowel habits, and abdominal pain. There's also a risk of infection transmission through the transplant material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe artery blockage not caused by common risk factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 12 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 plasma levels of metabolites of the intestinal microbiome

Metagenomic changes of the intestinal microbiome

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

Capsules of stool from Protected donors, cloxacillin, electrolyte purgative (Peglyte)

Group II: PlaceboPlacebo Group1 Intervention

Cellulose capsules, cloxacillin, electrolyte purgative (Peglyte)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor

241 Previous Clinical Trials

57,357 Total Patients Enrolled

European Bioinformatics InstituteUNKNOWN

1 Previous Clinical Trials

100 Total Patients Enrolled

J. David Spence, M.D.Principal InvestigatorWestern University, Canada

1 Previous Clinical Trials

95 Total Patients Enrolled

Frequently Asked Questions

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

Are there ongoing efforts to enroll participants in this research study?

"As per the details available on clinicaltrials.gov, this research trial is currently actively seeking eligible candidates. The initial posting date was recorded as June 2nd, 2020, with the most recent update dated April 23rd, 2024."

Answered by AI

What are the safety considerations of Active for individuals?

"Given that this is a Phase 1 trial with restricted safety and efficacy data, the team at Power has rated Active's safety as 1 on a scale of 3."

Answered by AI

How many individuals will be participating in this medical study overall?

"Yes, data on clinicaltrials.gov indicates that this medical study is presently enrolling subjects. The trial was first made available on June 2nd, 2020 and last updated on April 23rd, 2024. Recruitment aims to include a total of 100 participants at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis

2020. "Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04410003.

All > Atherosclerosis > Microbiome