Effects of gut bacteria on weight loss in pancreatic cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the impact of fecal microbiota transplantation (FMT) from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, as well as healthy volunteers, on cachexia-related parameters in germ-free mice. The study involves collecting fecal samples from 12 pancreatic cancer patients at diagnosis, before any treatment, and from 12 healthy age- and sex-matched volunteers. The effects of these samples will be assessed over a 30-day period in 96 germ-free mice to determine how the microbiota influences weight gain and cachexia. The hypothesis is that FMT from cachectic patients will impair weight gain compared to FMT from non-cachectic patients and healthy controls.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with pancreatic cancer (n=12)

* ≥18 years and
* Newly diagnosed of pancreatic adenocarcinoma (local or metastatic) and
* Tube feeding or parenteral nutrition ≤ 14 days

Cachectic pancreatic cancer patients (n=6)

* Cachexia according to the Fearon criteria 1: involuntary weight loss \>5% over the last 6 months, or any level of weight loss \>2% and a BMI \<20 kg/m2 or sarcopenia. Sarcopenia will be diagnosed by BIA (fat-free mass index is \<17 kg/m2 in men and \<15 kg/m2 in women) 81, and not by CT, as it is faster and can be performed at the bedside of the patient. Non-cachectic pancreatic cancer patients (n=6)
* Normal nutritional state: weight stability (± 2% of habitual weight) over the last 6 months, no anorexia before the diagnosis (appetite rating on a visual analogue scale of 100mm), no known impaired glucose tolerance.

Healthy matched subjects (n=12)

* ≥18 years and
* BMI between 18.5 and 30 kg/m2 and
* Absence of chronic or acute disease and
* Matching for gender and age (± 5 years) with an included pancreatic cancer patient

Exclusion Criteria:

* \< 18 years or
* Inability to give consent or
* Insufficient knowledge of project language (French, German) or
* Pancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversion
* Known rheumatologic or immunologic diseases
* Therapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion

Where it's running

• Geneva University Hospitals
  Geneva, Switzerland Recruiting

Study contacts

• Principal investigator: Laurence Genton Graf, Prof — Geneva University Hospitals (HUG)
• Study coordinator: Laurence Genton Graf, Prof
• Email: laurence.genton@hcuge.ch
• Phone: +41 22 3729344

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.