Rectal CancerNCT05516641
Prebiotics in Rectal Cancer
A study testing Soluble Corn Fiber and Maltodextrin in people with Rectal Cancer, run by Ochsner Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Soluble Corn Fiber and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ochsner Medical Center
New Orleans, Louisiana, 70121
Heather Green, MS, 504-842-2157, colon.research@ochsner.org
Chase Zibilich, 504-842-2157, colon.research@ochsner.org
About this study
Official title: Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy
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.
Read the detailed 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.
- Conditions
- Rectal Cancer
- Being tested
- Soluble Corn Fiber, Maltodextrin
- Keywords
- stage II, stage III, microbiome, prebiotic, racial disparities
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Corn FiberDietary supplement
once daily additive to diet
MaltodextrinDietary supplement
once daily additive to diet
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Soluble Corn Fiber Receives: Dietary Supplement: Soluble Corn Fiber |
| Control | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Microbiome changes
To characterize the changes in the gut and tumor associated microbiome
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start25 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Li, MD, PhD, Principal investigator, Ochsner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516641
- Sponsor's protocol ID
- 2021.227
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT05516641
- Acronym / sponsor ID
- 2021.227
- Conditions
- Rectal Cancer
- Keywords
- stage II, stage III, microbiome, prebiotic, racial disparities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Dietary Supplement: Soluble Corn FiberSoluble Corn Fiber |
| Control | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble Corn Fiberonce daily additive to diet | Dietary supplement | Prebiotic |
| Maltodextrinonce daily additive to diet | Dietary supplement | Control |
Primary outcome
Gut Flora modulation
Time frame: 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
2 secondary outcomes
Microbiome changes
Time frame: 6 months
Immune Profile
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, MD, PhD principal investigator
Ochsner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble Corn Fiber and Maltodextrin in people with Rectal Cancer, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Flora modulation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.