Prebiotics in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516641
• Other study ID #: 2021.227
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2022
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Dietary Supplement:
• Soluble Corn Fiber
once daily additive to diet
• Maltodextrin
once daily additive to diet

Locations

Country	Name	City	State
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Microbiome changes	To characterize the changes in the gut and tumor associated microbiome	6 months
Secondary	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