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NCT Number: NCT06988150

Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Abrahm Levi

CONTACT

[email protected]

310-248-8084

Andrew E. Hendifar, M.D., M.P.H.

PRINCIPAL_INVESTIGATOR

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. SIBO in PDAC

    Time frame: At Screening Visit

    Assess the prevalence of SIBO in consecutive PDAC patients with clinically significant weight loss.

Secondary outcomes

  1. SIBO & Resection

    Time frame: At Screening Visit

    Assess the prevalence of SIBO in patients who have undergone pancreatic resection versus those who have not undergone resection.

Study contacts

Contact information is provided by the study sponsor or research team.

Abrahm Levi

CONTACT

[email protected]

310-248-8084

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

A Prospective Study to Assess the Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC) Patients With Weight Loss

Acronym: SIBO in PDAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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