Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03420443

Acronym

FIPIREX

Enrollment

Registered

2018-02-05

Start date

2008-11-30

Completion date

2015-11-30

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

radiotherapy, probiotics

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.

Interventions

DIETARY_SUPPLEMENTOat bran

45 g oat bran.

DIETARY_SUPPLEMENTOat bran and blueberry husks

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

DIETARY_SUPPLEMENTNo oral supplementation

No oral supplementation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Action of synbiotics on irradiated GI mucosa in rectal cancer treatment	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026