Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer

Colorectal Neoplasms Clinical Trial

Official title:

Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479907
• Other study ID #: SYNBIOTICSCOLON
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: May 11, 2016
• Start date: November 2010
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this double-blinded prospective randomised trial is to explore the potential benefits of early postoperative administration of Synbiotics (combination of prebiotics and probiotics) to patients who have undergone colectomy for cancer. The patients are randomised to either synbiotics or placebo administration at the day they are able to tolerate po liquid diet and for 15 days thereafter.

Primary end points of the study will be:

Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of Life Index)

Secondary end points will be:

-Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30

Description:

The study patients are randomized before surgery to receive either synbiotics (Synbiotics group) or placebo (Control group). Equal randomization is accomplished using a computer-generated random allocation schedule. The method of allocation concealment is sequentially numbered sealed opaque envelopes technique. Both synbiotics and placebo preparations are in foil-sealed sachets stored in identical numbered containers. Both study products are white powders, identical in weight, smell, and taste. Thus, the identity of the specific product is blind to participants, support staff and investigators for the entire duration of the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Colectomy for histologically proven colorectal adenocarcinoma

Exclusion Criteria:

• Pregnancy,

• hereditary cancer,

• history of inflammatory bowel disease,

• metastatic disease at presentation,

• emergency operation,

• major postoperative complications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Synbiotics
12 gr in 250 cc of water once daily X 15 days
• Placebo
12 gr in 250 cc of water once daily X 15 days

Locations

Country	Name	City	State
Greece	First Department of Propaedeutic Surgery of Athens Medical School, Hippocration General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively		2 years	No