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Prebiotics for Rectal Cancer
N/A
Recruiting
Led By Li Li, MD, PhD
Research Sponsored by Ochsner Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will study whether a specific gut microbiome modulating therapy can help improve outcomes in African American patients with CRC.
Who is the study for?
This trial is for adults over 18 with stage 2 or stage 3 rectal cancer who have agreed to follow the study rules and signed a consent form. Women must not be pregnant or breastfeeding. People can't join if they're allergic to corn/maltodextrin, have other medical conditions that complicate participation, or have had another type of cancer.Check my eligibility
What is being tested?
The trial is testing whether Soluble Corn Fiber and Maltodextrin, which are types of prebiotics, can affect gut bacteria in a way that might improve outcomes for African Americans with rectal cancer who face higher risks than the general population.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort such as bloating or gas due to changes in gut bacteria from taking prebiotics like Soluble Corn Fiber and Maltodextrin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gut Flora modulation
Secondary outcome measures
Immune Profile
Microbiome changes
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrebioticExperimental Treatment1 Intervention
Soluble Corn Fiber
Group II: ControlPlacebo Group1 Intervention
Maltodextrin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soluble Corn Fiber
2019
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Ochsner Health SystemLead Sponsor
93 Previous Clinical Trials
184,641 Total Patients Enrolled
Li Li, MD, PhDPrincipal InvestigatorOchsner
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is stage 2 or 3 rectal cancer.I am 18 years old or older.I am not pregnant or breastfeeding.I have a history of cancer other than the rectal cancer I am currently treating.
Research Study Groups:
This trial has the following groups:- Group 1: Prebiotic
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently seeking participants?
"Affirmative. The details on clinicaltrials.gov imply that enrollment for this trial is still ongoing; the protocol was initially published on July 25th 2022, with a subsequent modification made August 24th 2022. Recruitment of 20 volunteers needs to be achieved from one single site."
Answered by AI
What is the aggregate population involved in this trial?
"Affirmative. The clinical trial is actively recruiting, as indicated by the latest data on clinicaltrials.gov which was updated in August 24th 2022 after its initial posting back in July 25th 2022. This medical study requires a total of 20 participants to be recruited from just one centre."
Answered by AI
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