Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment

Rectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420443
• Other study ID #: LU1007-3
• Status: Completed
• Phase: N/A
• First received: November 8, 2017
• Last updated: February 2, 2018
• Start date: November 2008
• Est. completion date: November 2015

Study information

• Verified date: February 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Dietary Supplement:
• Oat bran
45 g oat bran.
• Oat bran and blueberry husks
13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.
• No oral supplementation
No oral supplementation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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