search
Back to results

Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment (FIPIREX)

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oat bran
Oat bran and blueberry husks
No oral supplementation
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Cancer focused on measuring radiotherapy, probiotics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rectal cancer/Adenocarcinoma recti
  • Informed Consent explained orally and written, understood, agreed and signed

Exclusion Criteria:

  • Diabetes Mellitus
  • Inflammatory bowel disease
  • Previous radiation to pelvis area
  • Ongoing steroid or immunosuppressive therapy
  • Ongoing antibiotics therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Oat bran

    Oat bran and blueberry husks

    No oral supplementation

    Arm Description

    45 g oat bran

    13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria.

    No oral supplementation.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 8, 2017
    Last Updated
    February 2, 2018
    Sponsor
    Region Skane
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03420443
    Brief Title
    Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment
    Acronym
    FIPIREX
    Official Title
    Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Skane

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer
    Keywords
    radiotherapy, probiotics

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oat bran
    Arm Type
    Experimental
    Arm Description
    45 g oat bran
    Arm Title
    Oat bran and blueberry husks
    Arm Type
    Experimental
    Arm Description
    13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria.
    Arm Title
    No oral supplementation
    Arm Type
    Other
    Arm Description
    No oral supplementation.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Oat bran
    Intervention Description
    45 g oat bran.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Oat bran and blueberry husks
    Intervention Description
    13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    No oral supplementation
    Intervention Description
    No oral supplementation.
    Primary Outcome Measure Information:
    Title
    Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
    Description
    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.
    Time Frame
    2 weeks
    Title
    Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
    Description
    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.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Rectal cancer/Adenocarcinoma recti Informed Consent explained orally and written, understood, agreed and signed Exclusion Criteria: Diabetes Mellitus Inflammatory bowel disease Previous radiation to pelvis area Ongoing steroid or immunosuppressive therapy Ongoing antibiotics therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bengt Jeppsson, Prof
    Organizational Affiliation
    University of Lund, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

    We'll reach out to this number within 24 hrs