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

Region Skane

Status: Completed

Conditions: Rectal Cancer

Treatments: Dietary Supplement: No oral supplementation; Dietary Supplement: Oat bran and blueberry husks; Dietary Supplement: Oat bran

Study type: Interventional

Funder types: Other

Identifiers

NCT03420443

LU1007-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Oat bran

Experimental group

Description:

45 g oat bran

Treatment:

Dietary Supplement: Oat bran

Oat bran and blueberry husks

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat bran and blueberry husks

No oral supplementation

Other group

Description:

No oral supplementation.

Treatment:

Dietary Supplement: No oral supplementation