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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

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