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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Theodoropoulos, University of Athens
ClinicalTrials.gov Identifier:
NCT01479907
First received: November 16, 2011
Last updated: May 11, 2016
Last verified: May 2016

November 16, 2011
May 11, 2016
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
Not Provided
Not Provided
Not Provided
 
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer

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

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.
Interventional
Not Provided
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
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2015
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01479907
SYNBIOTICSCOLON
No
No
Not Provided
George Theodoropoulos, University of Athens
University of Athens
Not Provided
Principal Investigator: George E Theodoropoulos University of Athens
University of Athens
May 2016

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