Prebiotics in Rectal Cancer

• Sponsor: Ochsner Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05516641
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Dietary Supplement: Soluble Corn Fiber; Dietary Supplement: Maltodextrin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy
• Actual Study Start Date: Jul 25, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prebiotic Soluble Corn Fiber	Dietary Supplement: Soluble Corn Fiber; once daily additive to diet
Placebo Comparator: Control Maltodextrin	Dietary Supplement: Maltodextrin; once daily additive to diet

Outcome Measures

Primary Outcome Measures

1. Gut Flora modulation [1 year]

   fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients

Secondary Outcome Measures

1. Microbiome changes [6 months]

   To characterize the changes in the gut and tumor associated microbiome

2. Immune Profile [6 months]

   To evaluate the impact of prebiotic fiber treatment and microbiome changes on the tumor immune profile known to be associated with favorable outcomes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ochsner Medical Center	New Orleans	Louisiana	United States	70121

Sponsors and Collaborators

• Ochsner Health System

Investigators

• Principal Investigator: Li Li, MD, PhD, Ochsner

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ochsner Health System
• ClinicalTrials.gov Identifier: NCT05516641
• Other Study ID Numbers: 2021.227
• First Posted: Aug 25, 2022
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ochsner Health System: stage II; stage III; microbiome; prebiotic; racial disparities
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Aug 25, 2022