Pancreatic AdenocarcinomaSIBO in PDACNCT06988150
Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)
An observational study of Pancreatic Adenocarcinoma and Weight Loss, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Weight Loss
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 14 Oct 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with pancreatic adenocarcinoma with clinically significant weight loss.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Abrahm Levi, 310-248-8084, abrahm.levi@cshs.org
Andrew E. Hendifar, M.D., M.P.H.
About this study
Official title: A Prospective Study to Assess the Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC) Patients With Weight Loss
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.
Read the 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.
- Conditions
- Pancreatic Adenocarcinoma, Weight Loss
- Keywords
- PDAC
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic adenocarcinoma with clinically significant weight loss. | Patients diagnosed with pancreatic adenocarcinoma with clinically significant weight loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIBO in PDAC
Assess the prevalence of SIBO in consecutive PDAC patients with clinically significant weight loss.
Measured: At Screening Visit
Secondary outcomes (1)
SIBO & Resection
Assess the prevalence of SIBO in patients who have undergone pancreatic resection versus those who have not undergone resection.
Measured: At Screening Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start14 Apr 2025
- Primary completion14 Oct 2028 (estimated)
- Study completion14 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Hendifar, MD, Cedars-Sinai Medical Center
- Investigators
- Andrew E. Hendifar, M.D., M.P.H., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988150
- Sponsor's protocol ID
- STUDY00004075
- Acronym
- SIBO in PDAC
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No