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

Completed

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Athens, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

synbiotics

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

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

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2015
First posted: Nov 28, 2011
Registry last updated: May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed