Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
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ClinicalTrials.gov Identifier: NCT01479907 |
Recruitment Status
:
Completed
First Posted
: November 28, 2011
Last Update Posted
: May 13, 2016
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Tracking Information | ||||
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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 |
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 |
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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 |
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Condition ICMJE | Colorectal Neoplasms | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | George Theodoropoulos, University of Athens | |||
Study Sponsor ICMJE | University of Athens | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |