Observational Study on Diet, Gut Bacteria, and Chemotherapy for Pancreatic Cancer

This observational study aims to understand how your diet and the bacteria in your gut (fecal microbiome) might affect how well chemotherapy works for pancreatic cancer. Researchers are looking at patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (a type of pancreatic cancer that can be removed by surgery). You would complete a dietary survey and provide a stool sample. The main goal is to see if there's a link between your diet, your gut bacteria, and how your cancer responds to chemotherapy. This study is currently unclear on its recruitment status and plans to enroll 87 participants.

Study design
This is an observational study involving 87 participants. It is not testing a new treatment but rather observing existing patterns.
What's involved
You would complete a dietary survey and provide a fecal (stool) sample during the study.
Compensation
Not stated in the trial record.
Follow-up
Your fecal microbiome will be measured through study completion, which is an average of two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06595160

Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy

Recruiting
Not specifiedAges 18+Observational
Emory University
~87 participants
Updated 2025-08-01 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fecal Microbiome Alpha Diversity
Measured over Through study completion, an average of two years
Borderline Resectable Pancreatic Ductal Adenocarcinoma
Resectable Pancreatic Ductal Adenocarcinoma
Stage I Pancreatic Cancer AJCC v8

NCT06595160

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Mihir M Shah · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

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Eligibility criteria

Inclusion

\* Age ≥ 18 years with signed informed consent form
Patients must have a histological diagnosis of PDAC
Resectable or borderline resectable PDAC on imaging

Exclusion

\* Patients with locally advanced and metastatic stage IV PDAC
Patients who have already received or completed neoadjuvant chemotherapy for PDAC
Patients with active malignancy receiving systemic therapy
  • Fecal Microbiome Alpha DiversityThrough study completion, an average of two years

    Continuous variables will be presented as median with interquartile range and categorical variables will be presented as frequencies. Univariate logistic regression will be used to compare alpha diversity (mean inverse Simpson index) and relative abundance of operational taxonomic units up to species level in PDAC patients with and without major pathological response to neoadjuvant chemotherapy. Multivariable logistic regression analyses will be performed to identify significant factors associated with major pathological response after adjusting for age, gender, stage at presentation, and type of neoadjuvant chemotherapy and other factors based on univariate analyses or clinical significance.