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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

November 16, 2011
November 25, 2011
November 2010
March 2012   (final data collection date for primary outcome measure)
Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01479907 on ClinicalTrials.gov Archive Site
Not Provided
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Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Not Provided

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

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Colorectal Neoplasms
  • Dietary Supplement: Synbiotics
    12 gr in 250 cc of water once daily X 15 days
  • Dietary Supplement: Placebo
    12 gr in 250 cc of water once daily X 15 days
  • Active Comparator: Synbiotics
    Intervention: Dietary Supplement: Synbiotics
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: George E Theodoropoulos, MD, PhD, FACS +306945463593 georgetheocrs@live.com
Greece
 
NCT01479907
SYNBIOTICSCOLON
No
George Theodoropoulos, University of Athens
University of Athens
Not Provided
Not Provided
University of Athens
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP