Role of Diet and Faecal Microbiota Transplantation following Bowel Cancer Surgery

Not Applicable

• Conditions: ow Anterior Resection Syndrome; Low Anterior Resection; Bowel cancer; Low Anterior Resection Syndrome; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Diet and Nutrition - Other diet and nutrition disorders; Surgery - Other surgery; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12621001193864
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-06
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

i.Ileostomy reversed with background of LAR or ULAR due to adenocarcinoma of the colon or rectum
ii.Minor or Major Low Anterior Resection Syndrome (LARS)
iii.>18 years of age

Exclusion Criteria

i.Metastatic colorectal cancer (stage IV)
ii.Inflammatory Bowel Disease
iii.Patients with dementia
iv.Inability to provide informed consent
v.Permanent ileostomy/colostomy
vi.Planned for post-operative radiotherapy
vii.Autoimmune disease (uncontrolled) or on steroids (systemic) i.e. prednisolone
viii.Anaphylactic food allergy
ix.Neutropenia (<1)
x.Pregnant or breast feeding
xi.Use of probiotics, once recruited

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bowel function assessed via Low Anterior Resection Syndrome (LARS) questionnaire [At baseline (week 0) and week 4 post intervention commencement.];General quality of life (QoL) assessed via Cancer Quality of Life-general post cancer questionnaire (EORTC QLQ-C30) [At baseline (week 0) and week 4 post intervention commencement.];Colorectal specific quality of life (QoL) assessed via Colorectal specific QoL (EORTC QLQ-C30) questionnaire [At baseline (week 0) and week 4 post intervention commencement.]

Secondary Outcome Measures

Name	Time	Method
Composite outcome of gut microbiota composition and diversity via 16S rRNA gene sequencing of a stool sample.[At baseline (week 0) and week 4 post intervention commencement.];Inflammation assessed via Faecal calprotectin from blood sample [At baseline (week 0) and week 4 post intervention commencement.];Immune response via full blood count from blood sample<br>[At baseline (week 0) and week 4 post intervention commencement.]