Analyzing bacterial overgrowth in pancreatic cancer patients
A Prospective Study to Assess the Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC) Patients With Weight Loss
This study is testing how common bacterial overgrowth is in pancreatic cancer patients who are losing weight and seeing if it relates to their surgery status.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06988150 on ClinicalTrials.gov |
What this trial studies
This observational study aims to prospectively analyze the prevalence of small intestinal bacterial overgrowth (SIBO) in patients diagnosed with pancreatic adenocarcinoma (PDAC) who are experiencing clinically significant weight loss. The study will enroll 100 patients and utilize the Lactulose Hydrogen Breath Test to assess SIBO presence. Additionally, it will explore the association between SIBO prevalence and the patients' pancreatic resection status. The findings could enhance understanding of the gastrointestinal complications faced by PDAC patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of pancreatic ductal adenocarcinoma and clinically significant weight loss.
Not a fit: Patients who are minors, pregnant, or have received treatment for SIBO in the past three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of weight loss and nutritional deficiencies in pancreatic cancer patients.
How similar studies have performed: While there is limited understanding of SIBO prevalence in PDAC patients, similar studies have indicated potential associations between gastrointestinal issues and pancreatic cancer, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men, Women, and all genders * Individuals 18 years old or older are included. * Patients of the study investigators and team members * Diagnosis of pancreatic ductal adenocarcinoma * All subjects must consent to this study * Clinically diagnosed weight loss Exclusion Criteria: * Minors * Pregnant Women * Any records flagged "break the glass" or "research opt out." * Patients who have received treatment for SIBO in the past 3 months
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Andrew E. Hendifar, M.D., M.P.H. — Cedars-Sinai Medical Center
- Study coordinator: Abrahm Levi
- Email: abrahm.levi@cshs.org
- Phone: 310-248-8084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.