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Prebiotics in Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soluble Corn Fiber
Maltodextrin
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rectal Cancer focused on measuring stage II, stage III, microbiome, prebiotic, racial disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ochsner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prebiotic

Control

Arm Description

Soluble Corn Fiber

Maltodextrin

Outcomes

Primary Outcome Measures

Gut Flora modulation
fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients

Secondary Outcome Measures

Microbiome changes
To characterize the changes in the gut and tumor associated microbiome
Immune Profile
To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes

Full Information

First Posted
August 23, 2022
Last Updated
March 28, 2023
Sponsor
Ochsner Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05516641
Brief Title
Prebiotics in Rectal Cancer
Official Title
Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ochsner Health System

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
stage II, stage III, microbiome, prebiotic, racial disparities

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prebiotic
Arm Type
Experimental
Arm Description
Soluble Corn Fiber
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Soluble Corn Fiber
Intervention Description
once daily additive to diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
once daily additive to diet
Primary Outcome Measure Information:
Title
Gut Flora modulation
Description
fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Microbiome changes
Description
To characterize the changes in the gut and tumor associated microbiome
Time Frame
6 months
Title
Immune Profile
Description
To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Li, MD, PhD
Organizational Affiliation
Ochsner
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Green, MS
Phone
504-842-2157
Email
colon.research@ochsner.org
First Name & Middle Initial & Last Name & Degree
Chase Zibilich
Phone
504-842-2157
Email
colon.research@ochsner.org
First Name & Middle Initial & Last Name & Degree
Li Li, MD, PhD
First Name & Middle Initial & Last Name & Degree
Brian Kann, MD
First Name & Middle Initial & Last Name & Degree
H. David Vargas, MD
First Name & Middle Initial & Last Name & Degree
William Johnston, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Paruch, MD
First Name & Middle Initial & Last Name & Degree
Charles Whitlow, MD
First Name & Middle Initial & Last Name & Degree
William Kethman, MD
First Name & Middle Initial & Last Name & Degree
Marc Matrana, MD
First Name & Middle Initial & Last Name & Degree
Jonathan Mizrahi, MD
First Name & Middle Initial & Last Name & Degree
Daniel Johnson, MD

12. IPD Sharing Statement

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Prebiotics in Rectal Cancer

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