Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
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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 |
- 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 |
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| Contact: George E Theodoropoulos, MD, PhD, FACS | +306945463593 | georgetheocrs@live.com |
| 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 | |
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 May 23, 2013