Prebiotics in Rectal Cancer

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: Rectal Cancer
• Intervention / Treatment: Dietary supplement: Soluble Corn Fiber; Dietary supplement: Maltodextrin

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

Study Locations

• United States
  • 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

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic; Soluble Corn Fiber	Dietary supplement: Soluble Corn Fiber; once daily additive to diet
Placebo Comparator: Control; Maltodextrin	Dietary supplement: Maltodextrin; once daily additive to diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome changes	To characterize the changes in the gut and tumor associated microbiome	6 months
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	6 months

Collaborators and Investigators

• Sponsor: Ochsner Health System
• Investigators: Principal Investigator: Li Li, MD, PhD, Ochsner

Study record dates

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

• Keywords: prebiotic; stage III; microbiome; stage II; racial disparities
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• 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