Gastrointestinal DiseasesNCT07424469
Foregut Leaks-Role of Microbiome
A study testing Biopsy and fluid samples in people with Gastrointestinal Diseases, run by Baylor Research Institute at 1 site in United States.
Trial summary
Aims 1. To understand the microbial composition involved with foregut leaks 2. To define the virulence changes in the microbiota following foregut leaks 3. To identify host response mechanisms and how they change with interventions 4. Utilize this information to improve patient outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Biopsy and fluid samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an esophageal or stomach leak
- Over 18 years old
Who cannot join
- Patients determined by physician/surgeon as not able to tolerate biopsy
- Under 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White Center for Advanced Surgery
Dallas, Texas, 75246
Rehma Shabbir, 214-820-1722, Rehma.Shabbir@BSWHealth.org
About this study
Official title: The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes
Aims
- To understand the microbial composition involved with foregut leaks
- To define the virulence changes in the microbiota following foregut leaks
- To identify host response mechanisms and how they change with interventions
- Utilize this information to improve patient outcomes
Read the detailed description
For this study, investigators will compare the microbial composition of the infected fluid from the leak to that of a tissue sample taken from the participant. This will allow investigators to compare the composition and virulence of the microbiome both within and between participants. These comparisons will help further the understanding of the pathogenesis of these leaks, as well as identify which participants may be most at risk of developing postoperative leaks. The combination of this information has the potential to contribute to the development of preventative measures and improve patient outcomes.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Biopsy and fluid samples
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy and fluid samplesOther
Biopsy and fluid samples taken during other medically necessary procedure
| Study group | Role | What they receive |
|---|---|---|
| Sample collection | Other | Samples of microbial fluid and host biopsy taken Receives: Other: Biopsy and fluid samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial composition of samples
change in virulence factors, microbial response to treatment modalities
Measured: During the surgery
Time of healing of leaks
Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation.
Measured: From index intervention until documented leak resolution ( up to 24 weeks)
Proportion of patients achieving leak closure without need for additional surgical intervention
Successful endoscopic management will be defined as complete leak resolution without requirement for subsequent operative surgical repair. This will be measured as a percentage of participants.
Measured: Up to 24 weeks post-surgery
Incidence of postoperative complications
Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded.
Measured: Within 30 days post-surgery
Secondary outcomes (2)
Patient demographics
age, sex, race, ethnicity
Measured: Baseline or anytime before surgery
Patient risk of postoperative complications
Calculated by ACS risk calculator
Measured: Post surgery until the time leak is healed ( up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start14 Aug 2020
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424469
- Sponsor's protocol ID
- 020-307
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes
- ClinicalTrials.gov ID
- NCT07424469
- Acronym / sponsor ID
- 020-307
- Conditions
- Gastrointestinal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims
- To understand the microbial composition involved with foregut leaks
- To define the virulence changes in the microbiota following foregut leaks
- To identify host response mechanisms and how they change with interventions
- Utilize this information to improve patient outcomes
Detailed description
For this study, investigators will compare the microbial composition of the infected fluid from the leak to that of a tissue sample taken from the participant. This will allow investigators to compare the composition and virulence of the microbiome both within and between participants. These comparisons will help further the understanding of the pathogenesis of these leaks, as well as identify which participants may be most at risk of developing postoperative leaks. The combination of this information has the potential to contribute to the development of preventative measures and improve patient outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample collection | Other | Other: Biopsy and fluid samplesSamples of microbial fluid and host biopsy taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with an esophageal or stomach leak
- Over 18 years old
Key exclusion criteria (2 listed)
- Patients determined by physician/surgeon as not able to tolerate biopsy
- Under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy and fluid samplesBiopsy and fluid samples taken during other medically necessary procedure | Other | Sample collection |
Primary outcome
Microbial composition of samples
Time frame: During the surgery
change in virulence factors, microbial response to treatment modalities
Time of healing of leaks
Time frame: From index intervention until documented leak resolution ( up to 24 weeks)
Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation.
Proportion of patients achieving leak closure without need for additional surgical intervention
Time frame: Up to 24 weeks post-surgery
Successful endoscopic management will be defined as complete leak resolution without requirement for subsequent operative surgical repair. This will be measured as a percentage of participants.
Incidence of postoperative complications
Time frame: Within 30 days post-surgery
Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded.
2 secondary outcomes
Patient demographics
Time frame: Baseline or anytime before surgery
Patient risk of postoperative complications
Time frame: Post surgery until the time leak is healed ( up to 24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy and fluid samples in people with Gastrointestinal Diseases, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rehma Shabbir (2148201722, Rehma.Shabbir@BSWHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial composition of samples (time frame: During the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.