Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment
FIPIREX
Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2008
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedFebruary 5, 2018
February 1, 2018
7 years
November 8, 2017
February 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
2 weeks
Study Arms (3)
Oat bran
EXPERIMENTAL45 g oat bran
Oat bran and blueberry husks
EXPERIMENTAL13 g freeze dried blueberry husks and 22 g oat bran + probiotic bacteria.
No oral supplementation
OTHERNo oral supplementation.
Interventions
13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.
Eligibility Criteria
You may qualify if:
- Rectal cancer/Adenocarcinoma recti
- Informed Consent explained orally and written, understood, agreed and signed
You may not qualify if:
- Diabetes Mellitus
- Inflammatory bowel disease
- Previous radiation to pelvis area
- Ongoing steroid or immunosuppressive therapy
- Ongoing antibiotics therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bengt Jeppsson, Prof
University of Lund, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2017
First Posted
February 5, 2018
Study Start
November 1, 2008
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
February 5, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share