Clinical trial · Observational
Microbiota and Pancreatic Cancer Cachexia
Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study
NCT05606523CI-TRIAL-00083423EXTRArecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This monocentric study aims at evaluating the effects of fecal microbiota transplantation from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, and healthy volunteers on several cachexia-related parameters of germ-free mice.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Microbiota | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cachectic patients with pancreatic cancer
- description
- Measurements and sample collection at one timepoint.
- label
- Non-cachectic patients with pancreatic cancer
- description
- Measurements and sample collection at one timepoint.
- label
- Healthy volunteers
- description
- Measurements and sample collection at one timepoint.
Primary outcomes (1)
- measure
- Body weight changes in mice after fecal material transplantation.
- timeFrame
- Between days 0 and 30
- description
- Body weight (g)
Secondary outcomes (28)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.