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

Tracking Information
First Submitted Date ICMJE	November 16, 2011
First Posted Date ICMJE	November 28, 2011
Last Update Posted Date	May 13, 2016
Study Start Date ICMJE	November 2010
Actual Primary Completion Date	March 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 25, 2011)	Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively [ Time Frame: 2 years ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01479907 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Official Title ICMJE	Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Brief 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
Detailed 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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
Condition ICMJE	Colorectal Neoplasms
Intervention ICMJE	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
Study Arms	Active Comparator: Synbiotics A specific multistrain/multifi ber synbiotic composition of prebiotics and probiotics (Synbiotic Forte™, "IONIA" Pharmaceuticals, Athens, Greece) was administered at the active comparator arm of the study. It contained 10 [11] of each of four lactic acid bacteria (LAB): Pediococcus pentosaceus 5-33:3, Leuconostoc mesenteroides 32-77:1, Lactobacillus paracasei ssp. paracasei 19, and Lactobacillus plantarum 2362, and 2.5 g of each of the four fermentable fibers (prebiotics): b-glucan, inulin, pectin and resistant starch. The synbiotics were delivered in sachets and then mixed with water (12 g in 250 mLof water once daily). Th e treatment started on the day patients tolerated per os liquid intake (2nd-4th POD). The intervention period lasted 15 days. Intervention: Dietary Supplement: Synbiotics; Placebo Comparator: Placebo The patients belonging to the placebo comparator arm received only the 4 fi bers and no LAB (12 gin 250 mLof water once daily for 15 days). All the subjects were interviewed by a dedicated research fellow (KP) and reactions to the product, and any adverse events occurring in the 15-day period were recorded. Intervention: Dietary Supplement: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 25, 2011)	100
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2015
Actual Primary Completion Date	March 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Greece
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01479907
Other Study ID Numbers ICMJE	SYNBIOTICSCOLON
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	George Theodoropoulos, University of Athens
Study Sponsor ICMJE	University of Athens
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: George E Theodoropoulos University of Athens
PRS Account	University of Athens
Verification Date	May 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP