Rectal CancerFIPIREXNCT03420443
Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment
A study testing Oat bran, Oat bran and blueberry husks and No oral supplementation in people with Rectal Cancer, run by Region Skane.
Trial summary
The aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Oat bran, Oat bran and blueberry husks and No oral supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Nov 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal cancer/Adenocarcinoma recti
- Informed Consent explained orally and written, understood, agreed and signed
Who cannot join
- Diabetes Mellitus
- Inflammatory bowel disease
- Previous radiation to pelvis area
- Ongoing steroid or immunosuppressive therapy
- Ongoing antibiotics therapy
About this study
Official title: Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer
The aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer.
Read the detailed description
Thirty patients diagnosed with rectal cancer receiving short term radiation therapy 25 Gray (Gy) during one week preoperatively will be examined. The patients will be divided into three groups with ten patients in each group. One control group without no treatment/study product, one group receiving a test product of 45 g of oat bran and freezing medium only, and one group having a probiotic bacteria, Lactobacillus plantarum HEAL 19 (1010 CFU/g), freezed dried blueberry husks (13 g) and oat bran (22 g), corresponding to 8 g fibre per day in each of the two treated groups. The patients will consume the test product once a day 1 week before and during radiotherapy (2 weeks in total). Mucosal biopsies for microflora analysis and blood samples for analysis of SCFAs and cytokines will be collected at inclusion as well as faecal samples. After radiation therapy, at surgery, blood samples, faecal samples and mucosal biopsies are collected. Fresh faecal samples, blood samples and mucosal biopsies are stored at -80°C until analysis.
- Conditions
- Rectal Cancer
- Being tested
- Oat bran, Oat bran and blueberry husks, No oral supplementation
- Keywords
- radiotherapy, probiotics
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat branDietary supplement
45 g oat bran.
Oat bran and blueberry husksDietary supplement
13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.
No oral supplementationDietary supplement
No oral supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Oat bran | Experimental | 45 g oat bran Receives: Dietary Supplement: Oat bran |
| Oat bran and blueberry husks | Experimental | 13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria. Receives: Dietary Supplement: Oat bran and blueberry husks |
| No oral supplementation | Other | No oral supplementation. Receives: Dietary Supplement: No oral supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
Reaction of gastrointestinal mucosa in a clinical setting in patients with preoperative radiotherapy treatment of rectal cancer pre-treated with either a probiotic bacteria, blueberry husks and oat bran, oat bran only or no pre-treatment at all, measured by analysis of bacterial diversity.
Measured: 2 weeks
Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
Reaction of gastrointestinal mucosa in a clinical setting in patients with preoperative radiotherapy treatment of rectal cancer pre-treated with either a probiotic bacteria, blueberry husks and oat bran, oat bran only or no pre-treatment at all, measured by analysis of inflammation.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startNov 2008
- Primary completionNov 2015
- Study completionNov 2015
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.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bengt Jeppsson, Prof, Principal investigator, University of Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420443
- Sponsor's protocol ID
- LU1007-3
- Acronym
- FIPIREX
- Status last verified
- Feb 2018
- First submitted
- 8 Nov 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT03420443
- Acronym / sponsor ID
- FIPIREX / LU1007-3
- Conditions
- Rectal Cancer
- Keywords
- radiotherapy, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Feb 2018 (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.
The aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer.
Detailed description
Thirty patients diagnosed with rectal cancer receiving short term radiation therapy 25 Gray (Gy) during one week preoperatively will be examined. The patients will be divided into three groups with ten patients in each group. One control group without no treatment/study product, one group receiving a test product of 45 g of oat bran and freezing medium only, and one group having a probiotic bacteria, Lactobacillus plantarum HEAL 19 (1010 CFU/g), freezed dried blueberry husks (13 g) and oat bran (22 g), corresponding to 8 g fibre per day in each of the two treated groups. The patients will consume the test product once a day 1 week before and during radiotherapy (2 weeks in total). Mucosal biopsies for microflora analysis and blood samples for analysis of SCFAs and cytokines will be collected at inclusion as well as faecal samples. After radiation therapy, at surgery, blood samples, faecal samples and mucosal biopsies are collected. Fresh faecal samples, blood samples and mucosal biopsies are stored at -80°C until analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oat bran | Experimental | Dietary Supplement: Oat bran45 g oat bran |
| Oat bran and blueberry husks | Experimental | Dietary Supplement: Oat bran and blueberry husks13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria. |
| No oral supplementation | Other | Dietary Supplement: No oral supplementationNo oral supplementation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rectal cancer/Adenocarcinoma recti
- Informed Consent explained orally and written, understood, agreed and signed
Key exclusion criteria (5 listed)
- Diabetes Mellitus
- Inflammatory bowel disease
- Previous radiation to pelvis area
- Ongoing steroid or immunosuppressive therapy
- Ongoing antibiotics therapy
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 |
|---|---|---|
| Oat bran45 g oat bran. | Dietary supplement | Oat bran |
| Oat bran and blueberry husks13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria. | Dietary supplement | Oat bran and blueberry husks |
| No oral supplementationNo oral supplementation. | Dietary supplement | No oral supplementation |
Primary outcome
Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
Time frame: 2 weeks
Reaction of gastrointestinal mucosa in a clinical setting in patients with preoperative radiotherapy treatment of rectal cancer pre-treated with either a probiotic bacteria, blueberry husks and oat bran, oat bran only or no pre-treatment at all, measured by analysis of bacterial diversity.
Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
Time frame: 2 weeks
Reaction of gastrointestinal mucosa in a clinical setting in patients with preoperative radiotherapy treatment of rectal cancer pre-treated with either a probiotic bacteria, blueberry husks and oat bran, oat bran only or no pre-treatment at all, measured by analysis of inflammation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Bengt Jeppsson, Prof principal investigator
University of Lund, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Oat bran, Oat bran and blueberry husks and No oral supplementation in people with Rectal Cancer, run by Region Skane.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action of synbiotics on irradiated GI mucosa in rectal cancer treatment (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 5 Feb 2018.