Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Adenocarcinoma, Weight Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study to Assess the Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC) Patients With Weight Loss
Overview
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.
Detailed description
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.
Primary outcome measures
- SIBO in PDAC [Time frame: At Screening Visit]
Secondary outcome measures (1)
- SIBO & Resection [Time frame: At Screening Visit]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT06988150 · STUDY00004075