NCT01479907

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

November 16, 2011

Last Update Submit

May 11, 2016

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively

    2 years

Study Arms (2)

Synbiotics

ACTIVE COMPARATOR

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.

Dietary Supplement: Synbiotics

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

SynbioticsDIETARY_SUPPLEMENT

12 gr in 250 cc of water once daily X 15 days

Synbiotics
PlaceboDIETARY_SUPPLEMENT

12 gr in 250 cc of water once daily X 15 days

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colectomy for histologically proven colorectal adenocarcinoma

You may not qualify if:

  • Pregnancy,
  • hereditary cancer,
  • history of inflammatory bowel disease,
  • metastatic disease at presentation,
  • emergency operation,
  • major postoperative complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Propaedeutic Surgery of Athens Medical School, Hippocration General Hospital

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Study Officials

  • George E Theodoropoulos

    University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass Professor of Surgery, Athens Medical School

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 28, 2011

Study Start

November 1, 2010

Primary Completion

March 1, 2012

Study Completion

September 1, 2015

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)