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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Athens.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
George Theodoropoulos, University of Athens
ClinicalTrials.gov Identifier:
NCT01479907
First received: November 16, 2011
Last updated: November 25, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention
Colorectal Neoplasms
Dietary Supplement: Synbiotics
Dietary Supplement: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Synbiotics Dietary Supplement: Synbiotics
12 gr in 250 cc of water once daily X 15 days
Placebo Comparator: Placebo Dietary Supplement: Placebo
12 gr in 250 cc of water once daily X 15 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479907

Contacts
Contact: George E Theodoropoulos, MD, PhD, FACS +306945463593 georgetheocrs@live.com

Locations
Greece
First Department of Propaedeutic Surgery of Athens Medical School, Hippocration General Hospital Recruiting
Athens, Greece, 11527
Contact: George E Theodoropoulos, MD, PhD, FACS    +306945463593    georgetheocrs@live.com   
Principal Investigator: George E Theodoropoulos, MD, PhD         
Sub-Investigator: Kiriaki Peitsidou, MD         
Sub-Investigator: Nikolaos Memos, MD, PhD         
Sub-Investigator: George Zografos, MD, PhD         
Sponsors and Collaborators
University of Athens
  More Information

No publications provided

Responsible Party: George Theodoropoulos, Ass Professor of Surgery, Athens Medical School, University of Athens
ClinicalTrials.gov Identifier: NCT01479907     History of Changes
Other Study ID Numbers: SYNBIOTICSCOLON
Study First Received: November 16, 2011
Last Updated: November 25, 2011
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 01, 2014