An observational study in Pancreatic Adenocarcinoma and Weight Loss, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Cedars-Sinai Medical Center · Observational
The purpose of this study is to prospectively analyze the prevalence of SIBO in patients with Pancreatic adenocarcinoma (PDAC) and understand its association with weight loss and pancreatic resection status. Each patient will be tested for SIBO using Lactulose Hydrogen Breath Test. 100 patients with diagnosed pancreatic adenocarcinoma and clinically diagnosed weight loss will be enrolled in this study.
Small intestinal bacterial overgrowth syndrome (SIBO) is a condition defined by excessive (greater than 105 CFU/mL) or abnormal bacteria in the upper gastrointestinal tract resulting in unintentional weight loss, diarrhea, nutritional deficiencies and osteoporosis. In healthy individuals, the growth of any remaining bacteria in the stomach is limited by biliary and pancreatic secretions. The location of Pancreatic ductal adenocarcinoma (PDAC) on the pancreas head hinders these exocrine secretions from reaching the small intestine, leading to exocrine pancreatic insufficiency in pancreatic cancer patients. Patients with Pancreatic adenocarcinoma suffer from similar symptoms including weight loss, diarrhea, and nutritional deficiencies. SIBO has been linked to Exocrine Pancreatic Insufficiency or anatomical abnormalities, both consistent in PDAC patients, especially those who have undergone surgery. Post-pancreatoduodenectomy physiological changes disrupt the way enzymes are secreted, which affects exocrine and endocrine functions of the pancreas. Currently, there is a limited understanding of the prevalence of SIBO in PDAC patients.
The primary objective of this study is to assess the prevalence of SIBO in consecutive PDAC patients with clinically significant weight loss.
The secondary objective of this study is to assess the prevalence of SIBO in patients who have undergone pancreatic resection versus those who have not undergone resection.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 100 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.
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Patients diagnosed with pancreatic adenocarcinoma with clinically significant weight loss.
Exclusion Criteria:
Patients diagnosed with pancreatic adenocarcinoma with clinically significant weight loss.
SIBO in PDAC
Assess the prevalence of SIBO in consecutive PDAC patients with clinically significant weight loss.
Time frame: At Screening Visit
SIBO & Resection
Assess the prevalence of SIBO in patients who have undergone pancreatic resection versus those who have not undergone resection.
Time frame: At Screening Visit
Plan to share: No
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Cedars-Sinai Medical Center