Prebiotics in Rectal Cancer

Ochsner Health System

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Dietary Supplement: Soluble Corn Fiber; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT05516641

2021.227

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Prebiotic

Experimental group

Description:

Soluble Corn Fiber

Treatment:

Dietary Supplement: Soluble Corn Fiber

Control

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Maltodextrin