Colorectal NeoplasmsNCT01479907
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
A study testing Synbiotics in people with Colorectal Neoplasms, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Synbiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2010to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colectomy for histologically proven colorectal adenocarcinoma
Who cannot join
- Pregnancy,
- hereditary cancer,
- history of inflammatory bowel disease,
- metastatic disease at presentation,
- emergency operation,
- major postoperative complications
Trial locations and contacts
1 site in 1 country.
Greece1 site
First Department of Propaedeutic Surgery of Athens Medical School, Hippocration General Hospital
Athens, 11527
About this study
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:
Read more
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
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Synbiotics, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticsDietary supplement
12 gr in 250 cc of water once daily X 15 days
PlaceboDietary supplement
12 gr in 250 cc of water once daily X 15 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Theodoropoulos, University of Athens
- Investigators
- George E Theodoropoulos, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479907
- Sponsor's protocol ID
- SYNBIOTICSCOLON
- Status last verified
- May 2016
- First submitted
- 16 Nov 2011
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
- ClinicalTrials.gov ID
- NCT01479907
- Acronym / sponsor ID
- SYNBIOTICSCOLON
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotics | Active comparator | Dietary Supplement: SynbioticsA 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colectomy for histologically proven colorectal adenocarcinoma
Key exclusion criteria (6 listed)
- Pregnancy,
- hereditary cancer,
- history of inflammatory bowel disease,
- metastatic disease at presentation,
- emergency operation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotics12 gr in 250 cc of water once daily X 15 days | Dietary supplement | Synbiotics |
| Placebo12 gr in 250 cc of water once daily X 15 days | Dietary supplement | Placebo |
Primary outcome
Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George E Theodoropoulos principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotics in people with Colorectal Neoplasms, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.