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2022-08-01
2025-04-30
2025-04-30
24
NCT05606523
University Hospital, Geneva
University Hospital, Geneva
OBSERVATIONAL
Microbiota and Pancreatic Cancer Cachexia
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.
Aim: Evaluating the effects of fecal microbiota transplantation (FMT) from 6 newly diagnosed cachectic and 6 non-cachectic pancreatic cancer patients, and 12 healthy age-and sex-matched volunteers on several cachexia-related parameters of 96 germ-free mice (4 per donor) over a 30-day period. The fecal material of all 12 pancreatic cancer patients will be collected at diagnosis before any cancer treatment onset. Hypothesis: FMT of cachectic patients with pancreas cancer, naïve of any anti-cancer treatment and artificial nutrition, into germ-free mice impairs weight gain, in contrast to FMT of non-cachectic patients and healthy controls.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-08-25 | N/A | 2024-12-03 |
2022-10-31 | N/A | 2024-12-06 |
2022-11-04 | N/A | 2024-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Cachectic patients with pancreatic cancer Measurements and sample collection at one timepoint. | |
| : Non-cachectic patients with pancreatic cancer Measurements and sample collection at one timepoint. | |
| : Healthy volunteers Measurements and sample collection at one timepoint. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Body weight changes in mice after fecal material transplantation. | Body weight (g) | Between days 0 and 30 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Differences in fecal microbiota | by 16S rRNA gene amplicon sequencing and functional profiles by metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Body weight | in kilograms between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Waist-to-hip ratio | waist circumference (cm) and hip circumference (cm) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Fat mass | by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Fat-free mass | by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Muscle mass | surfaces of the paraspinal and abdominal wall muscles at the level of L3-L4 disk space by CT for pancreatic cancer patients | at diagnosis |
| Nutritional intake | by 3-day food diary between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Resting energy expenditure (REE) | by indirect calorimetry between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by visual analogue scale ranging from 0 to 100 mm between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma ghrelin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma leptin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma glucagon-like peptide-1 (GLP-1) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma neuropeptide Y between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma cholecystokinin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Homeostatic model assessment (HOMA)-score | by fasting glycemia (mmol/l) and fasting insulinemia (mU/ml)) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Glycemia | by fasting glycemia (mmol/l) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Insulinemia | by fasting insulinemia (mU/ml) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Physical function | by handgrip strength between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Physical activity | by the International Physical Activity Questionnaire (IPAQ) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Quality of life | by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC QLQ-C30) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Mortality | by tumor progression between cachectic patients non-cachectic patients | at diagnosis |
| Oral microbiota | by 16SrRNA gene amplicon sequencing and metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Epithelial permeability | by fasting levels of plasma zonulin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Epithelial permeability | by fasting levels of plasma lipopolysaccharide-binding protein between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Epithelial permeability | by fasting levels of plasma glucagon-like peptide-2 between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| GALT function and systemic inflammation | by fasting plasma level of C-reactive protein (CRP) and cytokines between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| GALT function and systemic inflammation | by peripheral blood T regulatory cells (Tregs) levels and phenotype between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| GALT function and systemic inflammation | by myeloid derived suppressor cells (MDSC) levels and phenotype between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Laurence Genton Graf, Prof Phone Number: +41 22 3729344 Email: laurence.genton@hcuge.ch |
Study Contact Backup Name: Alexandra Hemmer, MSc Phone Number: +41795530491 Email: alexandra.hemmer@hcuge.ch |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
