50 Participants NeededMy employer runs this trial

Microbiome Study for Gastrointestinal Disorders

RS
Overseen ByRehma Shabbir
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the role of tiny organisms (microbes) in the gut when leaks occur in the esophagus or stomach. Researchers seek to determine how these microbes change and how the body reacts to the leaks. By studying these changes, they aim to improve treatment and recovery for patients. Participants will provide samples of their gut fluid and tissue through biopsy and fluid samples. This trial is suitable for individuals who have experienced an esophageal or stomach leak. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could lead to better treatments for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the role of the microbiome in gastrointestinal disorders, which is a new frontier in medical science. Unlike traditional treatments that often target symptoms directly, this approach focuses on understanding the underlying microbial environment within the gut. By collecting microbial fluid and host biopsy samples, scientists hope to uncover new insights into how gut bacteria influence digestive health, potentially leading to more personalized and effective treatment strategies. This could revolutionize the way we approach gastrointestinal disorders, moving beyond symptom management to targeting root causes.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have a leak in their esophagus or stomach. People without these leaks or under 18 cannot participate.

Inclusion Criteria

I have an esophageal or stomach leak.
I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Samples of microbial fluid and host biopsy taken for analysis

During surgery

Treatment

Participants undergo interventions to manage and heal foregut leaks

Up to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Biopsy and fluid samples

Trial Overview

Researchers will collect tissue and fluid samples from patients with foregut (esophageal or stomach) leaks to study the types of microbes present and how they change, aiming to better understand infection risks and healing.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Sample collectionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+