Recruiting

Prebiotics

Sponsor:

Ochsner Health System

Code:

NCT05516641

Conditions

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Soluble Corn Fiber

Maltodextrin

Study Details

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.

Conditions

Rectal Cancer

Study ID

NCT05516641

Start date

Jul 25, 2022

Status verified date

Aug, 2022

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Prebiotic

Soluble Corn Fiber

placebo comparator: Control

Maltodextrin

Interventions

Soluble Corn Fiber

once daily additive to diet

Maltodextrin

once daily additive to diet

Primary outcome measure

  • Gut Flora modulation [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Ochsner Medical Center

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Heather Green, MS

504-842-2157colon.research@ochsner.org

Chase Zibilich

504-842-2157colon.research@ochsner.org

Principal Investigator:

Li Li, MD, PhD

More Information

Sponsor

Ochsner Health System

Last update posted

Mar 31, 2023

Last verified

Aug, 2022

Keywords

  • stage II
  • stage III
  • microbiome
  • prebiotic
  • racial disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2023-03-31.