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Completed

NCT Number: NCT03420443

Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oat bran

Dietary Supplement

45 g oat bran.

Oat bran and blueberry husks

Dietary Supplement

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

No oral supplementation

Dietary Supplement

No oral supplementation.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer

Acronym: FIPIREX

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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