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Fecal Microbiota Transplantation for Pancreatic Cancer
Study Summary
This trial is testing whether fecal microbial transplants are safe and effective in treating patients with pancreatic cancer that is scheduled for surgery to remove tumors. Fecal microbial transplants contain the normal microbes found in fecal (stool) material and it is hoped that it will help control the disease.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844Trial Design
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Who is running the clinical trial?
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- I am not allergic to antibiotics, loperamide, or laxatives.I am 18 years old or older.I am under 18 years old.My pancreatic cancer is in the early stage (Stage T1N0).I haven't taken antibiotics in the last 48 hours.I have a history of inflammatory bowel disease or radiation-induced bowel problems.I am willing and able to sign a consent form.I do not have any ongoing infections.My kidneys are working well, with a creatinine clearance over 30 mL/min.I am a woman who could become pregnant and have not had a negative pregnancy test.I have been diagnosed with an immune system disorder.My white blood cell count is high or I've had a fever over 38°C.My stomach empties slowly.I have had a blockage in my intestines before.My existing health condition has recently gotten worse.I am either male or female.I agree to have a biopsy and colonoscopy for treatment.I can take care of myself and am up and about more than half of my waking hours.My liver tests are within normal limits.I have pancreatic cancer and am expected to undergo Whipple surgery.I have trouble swallowing or frequently inhale food or liquid into my lungs.My immune system is very weak.
- Group 1: Treatment (FMT, FMT capsules)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who is eligible to take part in this clinical experiment?
"This medical trial is accepting 10 individuals between the legal age of consent and 70 years old who have been diagnosed with pancreatic adenocarcinoma (ductal adenocarcinoma). These patients must be seen at MD Anderson Cancer Center, possess adequate hematological functions, demonstrate appropriate hepatic capabilities, present satisfactory renal functioning, agree to sign an informed consent form, provide blood and stool samples for research purposes along with a baseline core biopsy and colonoscopy for FMT delivery."
Are there any available openings in this experiment currently?
"Per the data posted on clinicaltrials.gov, enrollment for this medical trial has been ongoing since December 14th 2021 and is currently active as of October 20th 2022."
Does this study accept participants who are above the age of thirty?
"The eligible age range for this experiment is 18-70 years old. Separately, there are 1 clinical trials targeting minors and 92 medical studies that focus on individuals aged 65 or more."
How many participants are being accepted into this research project?
"Affirmative, the information publicly available on clinicaltrials.gov reveals that this investigation is actively enrolling participants. The trial was first launched on December 14th 2021 and was recently updated in October 2022. Thus far 10 patients have been accepted at 1 centre for testing."
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