NCT05516641

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 31, 2023

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 23, 2022

Last Update Submit

March 28, 2023

Conditions

Rectal Cancer

Keywords

stage IIstage IIImicrobiomeprebioticracial disparities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Microbiome changes

    6 months

  • Immune Profile

    6 months

Study Arms (2)

Prebiotic

EXPERIMENTAL

Soluble Corn Fiber

Dietary Supplement: Soluble Corn Fiber

Control

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Maltodextrin

Interventions

Soluble Corn FiberDIETARY_SUPPLEMENT

once daily additive to diet

Prebiotic
MaltodextrinDIETARY_SUPPLEMENT

once daily additive to diet

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Clinical diagnosis of stage 2 or stage 3 rectal cancer
  • Subjects who are women of child-bearing potential must not be pregnant or lactating
  • Have signed an approved informed consent form for the study
  • Be willing to comply with the protocol

You may not qualify if:

  • Patients with a cancer history (excluding the rectal cancer currently being addressed)
  • Allergic to corn or maltodextrin
  • Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Li Li, MD, PhD

    Ochsner

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

July 25, 2022

Primary Completion

December 31, 2023

Study Completion

July 31, 2024

Last Updated

March 31, 2023

Record last verified: 2022-08

Locations

US(1)