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Trial Title:
Prebiotics in Rectal Cancer
NCT ID:
NCT05516641
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
stage II
stage III
microbiome
prebiotic
racial disparities
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Soluble Corn Fiber
Description:
once daily additive to diet
Arm group label:
Prebiotic
Intervention type:
Dietary Supplement
Intervention name:
Maltodextrin
Description:
once daily additive to diet
Arm group label:
Control
Summary:
A significant racial disparity in the incidence and mortality of CRC exists in the U.S.
with African Americans having CRC incidence and mortality rates that are 20% and 40%
higher than the general U.S. population. It has been demonstrated that the gut microbiome
impacts tumor development and progression through multiple mechanisms, including
impacting the tumoral immune response. However, it is unknown if microbiome modulating
treatment can have an impact on CRC outcomes.
Detailed description:
A significant racial disparity in the incidence and mortality of CRC exists in the U.S.
with African Americans having CRC incidence and mortality rates that are 20% and 40%
higher than the general U.S. population. It has been demonstrated that the gut microbiome
impacts tumor development and progression through multiple mechanisms, including
impacting the tumoral immune response. However, it is unknown if microbiome modulating
treatment can have an impact on CRC outcomes.
This is a pilot project to see if any changes are detected in stool and/or tissue samples
in rectal cancer patients who receive a soluble corn fiber supplement during their
neoadjuvant treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18 years or older
2. Clinical diagnosis of stage 2 or stage 3 rectal cancer
3. Subjects who are women of child-bearing potential must not be pregnant or lactating
4. Have signed an approved informed consent form for the study
5. Be willing to comply with the protocol
Exclusion Criteria:
1. Patients with a cancer history (excluding the rectal cancer currently being
addressed)
2. Allergic to corn or maltodextrin
3. Has, in the Investigator's opinion, any medical condition that makes the subject a
poor candidate for the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ochsner Medical Center
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Green, MS
Phone:
504-842-2157
Email:
colon.research@ochsner.org
Contact backup:
Last name:
Chase Zibilich
Phone:
504-842-2157
Email:
colon.research@ochsner.org
Investigator:
Last name:
Li Li, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Brian Kann, MD
Email:
Sub-Investigator
Investigator:
Last name:
H. David Vargas, MD
Email:
Sub-Investigator
Investigator:
Last name:
William Johnston, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jennifer Paruch, MD
Email:
Sub-Investigator
Investigator:
Last name:
Charles Whitlow, MD
Email:
Sub-Investigator
Investigator:
Last name:
William Kethman, MD
Email:
Sub-Investigator
Investigator:
Last name:
Marc Matrana, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jonathan Mizrahi, MD
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Johnson, MD
Email:
Sub-Investigator
Start date:
July 25, 2022
Completion date:
July 31, 2024
Lead sponsor:
Agency:
Ochsner Health System
Agency class:
Other
Source:
Ochsner Health System
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05516641