Prebiotics in Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Soluble Corn Fiber

• Registration Number: NCT05516641
• Lead Sponsor: Ochsner Health System

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.

Study Timeline

• Study Start: 2022-07-25
• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-25
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Maltodextrin	Maltodextrin
Prebiotic	Soluble Corn Fiber	Soluble Corn Fiber

Primary Outcome Measures

Name	Time	Method
Gut Flora modulation	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

Secondary Outcome Measures

Name	Time	Method
Immune Profile	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
Microbiome changes	6 months	To characterize the changes in the gut and tumor associated microbiome

Trial Locations

Locations (1)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States