Prebiotics in Rectal Cancer
March 28, 2023 updated by: Ochsner Health System
Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Ochsner Medical Center
-
Contact:
- Heather Green, MS
- Phone Number: 504-842-2157
- Email: colon.research@ochsner.org
-
Contact:
- Chase Zibilich
- Phone Number: 504-842-2157
- Email: colon.research@ochsner.org
-
Principal Investigator:
- Li Li, MD, PhD
-
Sub-Investigator:
- Brian Kann, MD
-
Sub-Investigator:
- H. David Vargas, MD
-
Sub-Investigator:
- William Johnston, MD
-
Sub-Investigator:
- Jennifer Paruch, MD
-
Sub-Investigator:
- Charles Whitlow, MD
-
Sub-Investigator:
- William Kethman, MD
-
Sub-Investigator:
- Marc Matrana, MD
-
Sub-Investigator:
- Jonathan Mizrahi, MD
-
Sub-Investigator:
- Daniel Johnson, MD
-
-
Participation Criteria
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 years or older
- Clinical diagnosis of stage 2 or stage 3 rectal cancer
- Subjects who are women of child-bearing potential must not be pregnant or lactating
- Have signed an approved informed consent form for the study
- Be willing to comply with the protocol
Exclusion Criteria:
- Patients with a cancer history (excluding the rectal cancer currently being addressed)
- Allergic to corn or maltodextrin
- Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prebiotic
Soluble Corn Fiber
|
once daily additive to diet
|
|
Placebo Comparator: Control
Maltodextrin
|
once daily additive to diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gut Flora modulation
Time Frame: 1 year
|
fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiome changes
Time Frame: 6 months
|
To characterize the changes in the gut and tumor associated microbiome
|
6 months
|
|
Immune Profile
Time Frame: 6 months
|
To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li Li, MD, PhD, Ochsner
Study record dates
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 Major Dates
Study Start (Actual)
July 25, 2022
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
July 31, 2024
Study Registration Dates
First Submitted
August 23, 2022
First Submitted That Met QC Criteria
August 24, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.227
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.