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Microbiota Transplant

IMT group for Colon Resection

Phase 1

Recruiting

Led By Cyrus Jahansouz, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of surgery, post-op day 1-14, day30, day60, day90, day120, day150, day180

Awards & highlights

Study Summary

This trial is studying the safety and feasibility of a type of treatment called IMT in patients having colonic surgery. Patients with a history of diverticulitis will have a feeding tube placed during surgery

Who is the study for?

This trial is for adults aged 18-75 who have had diverticulitis and are undergoing colon resection surgery. Participants will receive either an intestinal microbiota transplant (IMT) or a saline solution through a feeding tube after surgery. They must meet certain health criteria, not be allergic to the materials used, and agree to follow-up assessments.Check my eligibility

What is being tested?

The study tests the safety of delivering IMT via a nasogastric feeding tube compared to a saline solution in patients post-colon surgery. It aims to see if this method is feasible without causing harm like bowel perforation or disrupting the surgical site.See study design

What are the potential side effects?

Potential side effects may include discomfort from the feeding tube, infection risk from IMT, and possible reactions related to changes in gut bacteria. Patients will be closely monitored for any serious adverse events (SAEs) or other side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of surgery, post-op day 1-14, day30, day60, day90, day120, day150, day180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of surgery, post-op day 1-14, day30, day60, day90, day120, day150, day180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery, post-op day 1-14, day30, day60, day90, day120, day150, day180 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluate safety of IMT in patients undergoing colon surgery

compare fecal microbiota prior to and after IMT

Secondary outcome measures

Compare baseline microbiome characteristics with changes over time after IMT

Evaluate changes in circulating markers of inflammation

Evaluate changes in circulating markers of inflammation: Electrolytes

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IMT groupExperimental Treatment1 Intervention

individuals of the ages of 18-75 with a history of diverticulitis will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT solution

Group II: Placebo groupPlacebo Group1 Intervention

individuals of the ages of 18-75 with a history of diverticulitis will be enrolled to have a feeding tube placed at the time of surgery and receive saline solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMT

2015

N/A

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,551,264 Total Patients Enrolled

Cyrus Jahansouz, MDPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

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

Has the IMT group received approval from the FDA?

"On a scale of 1 to 3, our research team at Power rates the safety of the IMT group as 1. This is due to it being classified as a Phase I trial with minimal data available regarding both efficacy and safety."

Answered by AI

What is the primary goal or purpose of this medical study?

"The primary aim of this clinical investigation, which will be assessed from approximately 60 days before to the day of surgery and up to post-operative Day 180, is to analyze the safety profile of IMT in patients undergoing colon surgery. Secondary endpoints encompass monitoring alterations in microbial metabolites: fecal short-chain fatty acids measured as millimoles per kilogram (mmol/kg) collected through blood samples with standard lab values provided; assessing changes in microbial metabolites: fecal IgA quantified as nanograms IgA per milligram stool (ng IgA/mg stool) calculated based on weight measurements; and evaluating modifications in circulating inflammatory"

Answered by AI

Is there an age restriction for participants in this medical study, specifically excluding individuals below the age of 45?

"Individuals wishing to participate in this research study must be between 18 and 75 years old."

Answered by AI

Who meets the criteria to participate in this medical study?

"To be considered for enrollment in this research study, individuals must have undergone colon resection and fall between the ages of 18 to 75. The trial aims to recruit approximately 20 eligible candidates."

Answered by AI

Are patients currently able to enroll in this ongoing clinical trial?

"Yes, as per clinicaltrials.gov, this investigation is currently seeking participants. It was first listed on February 1st, 2024 and last modified on April 12th, 2024. The study aims to enroll 20 patients from a single location."

Answered by AI

What is the current number of individuals receiving medical care as part of this research study?

"Affirmative. The details on clinicaltrials.gov specify that this study is actively seeking volunteers. It was initially uploaded on February 1st, 2024 and last revised on April 12th, 2024. A total of 20 participants are sought from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

2024. "Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06370884.

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