← Back to Search

Virus Therapy

Fecal Microbiota Transplantation for Pancreatic Cancer

Phase < 1
Recruiting
Led By Florencia McAllister
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after surgery
Awards & highlights

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.

Who is the study for?
This trial is for adults with pancreatic ductal adenocarcinoma scheduled for surgery. Participants must have normal liver and kidney function, not be pregnant or breastfeeding, able to give consent, provide samples, and not have had antibiotics in the last 48 hours. Exclusions include GI infections, immunodeficiency, swallowing issues, severe immune compromise, certain blood conditions or allergies to trial drugs.Check my eligibility
What is being tested?
The study tests fecal microbial transplants (FMT) via colonoscopy or capsules on patients with pancreatic cancer before tumor removal surgery. It aims to see if introducing healthy gut microbes can help control the disease. Patients will also complete questionnaires and undergo standard surgical procedures.See study design
What are the potential side effects?
Potential side effects may include discomfort from colonoscopy procedure; reactions to FMT such as bloating, cramps or changes in bowel habits; risk of infection transfer through stool material; and possible allergic reactions to any medications used during the process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events

Side effects data

From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844
44%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Vomiting
6%
Fatigue
4%
Heart Burn
4%
Chills
4%
Migraine
4%
Yeast Infection
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (FMT, FMT capsules)Experimental Treatment5 Interventions
Patients undergo FMT during colonoscopy. Patients also receive FMT capsules PO QW for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350
Resection
2021
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,311 Total Patients Enrolled
Florencia McAllisterPrincipal InvestigatorM.D. Anderson Cancer Center
Florencia McAllister, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Fecal Microbial Transplantation (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04975217 — Phase < 1
Pancreatic Cancer Research Study Groups: Treatment (FMT, FMT capsules)
Pancreatic Cancer Clinical Trial 2023: Fecal Microbial Transplantation Highlights & Side Effects. Trial Name: NCT04975217 — Phase < 1
Fecal Microbial Transplantation (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975217 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~5 spots leftby Dec 2026