Colorectal CancerPICCS-1NCT06456229
Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery
A study testing Nestle Isocal and Nestle Boost Optimum in people with Colorectal Cancer and Ileus Postoperative, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
There is pre-existing evidence that probiotics could be useful in the improvement of ileus rates. One metaanalysis of 30 studies demonstrated a reduction in the prevalence of post-operative ileus as determined by time to flatus, time to defecation, as well as postoperative abdominal distension (PMID:37373843). Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Colorectal Cancer, Ileus Postoperative, Flatus
- What is being tested?
- Nestle Isocal and Nestle Boost Optimum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2024to 1 May 2025
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective colorectal cancer surgery in which an oncologic resection is planned
- age between 21 and 99 years at the time of consent
- willing to consider oral nutritional supplementation
- on an early recovery after surgery (ERAS) pathway
- able to provide informed consent
Who cannot join
- patients with known contraindications to probiotic use
- patients undergoing emergency surgery
- taking any other form of probiotics
- taking oral antibiotics within 7 days of commencement of study
- vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Dedrick Chan, MBBS, DPhil
About this study
Official title: Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery (PICCS-1)
There is pre-existing evidence that probiotics could be useful in the improvement of ileus rates. One metaanalysis of 30 studies demonstrated a reduction in the prevalence of post-operative ileus as determined by time to flatus, time to defecation, as well as postoperative abdominal distension (PMID:37373843). More broadly in gastrointestinal surgery, a meta-analysis of 21 randomised controlled trials similarly affirmed the speedier recovery of gastrointestinal function after surgery when probiotics were administered (PMID: 35231076). In spite of these advantages, the routine use of probiotics perioperatively for colorectal cancer surgery is not performed in Singapore. We therefore seek to perform a trial to investigate whether probiotic administration perioperatively may reduce post operative ileus rates.
- Conditions
- Colorectal Cancer, Ileus Postoperative, Flatus, Diet, Healthy
- Being tested
- Nestle Isocal, Nestle Boost Optimum
- Keywords
- colorectal cancer, colorectal surgery, nutritional supplementation, probiotics, time to bowel movement, time to flatus, length of stay, complications
- Medical subject headings
- Colorectal Neoplasms, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestle IsocalDietary supplement
Nestle Isocal
Nestle Boost OptimumDietary supplement
Nestle Boost Optimum
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | Control arm with no nutritional supplementation |
| Arm 2 | Active comparator | Control arm with nutritional supplementation but without probiotics Receives: Dietary Supplement: Nestle Isocal |
| Arm 3 | Experimental | Nutritional supplementation with probiotics Receives: Dietary Supplement: Nestle Boost Optimum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to bowel movement
This records the number of days from the day of surgery before the first bowel movement was experienced by the patient.
Measured: 0 - 14 days
Secondary outcomes (4)
Time to flatus
This records the number of days from the day of surgery before the first flatus was experienced by the patient.
Measured: 0 - 14 days
Adverse events
Any adverse events related to the intervention. This comprises predominantly gastrointestinal related complications
Measured: From commencement of the intervention to 30 days after surgery
Infective complications
Any infective complications which may occur in the postoperative period.
Measured: From date of surgery to 30 days after surgery
Length of hospital stay
This records the number of days following surgery before the patient is discharged.
Measured: 0 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456229
- Sponsor's protocol ID
- 2024/00180
- Acronym
- PICCS-1
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Chan DKH, Siew BE, Lau J, Koh J, Lee MX, Ang C, Pang NQ, Tan KK. Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial. Trials. 2025 Feb 19;26(1):60. doi: 10.1186/s13063-025-08773-2.
PubMed 39972354
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery (PICCS-1)
- ClinicalTrials.gov ID
- NCT06456229
- Acronym / sponsor ID
- PICCS-1 / 2024/00180
- Conditions
- Colorectal Cancer, Ileus Postoperative, Flatus, Diet, Healthy
- Keywords
- colorectal cancer, colorectal surgery, nutritional supplementation, probiotics, time to bowel movement, time to flatus, length of stay, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- 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.
There is pre-existing evidence that probiotics could be useful in the improvement of ileus rates. One metaanalysis of 30 studies demonstrated a reduction in the prevalence of post-operative ileus as determined by time to flatus, time to defecation, as well as postoperative abdominal distension (PMID:37373843). More broadly in gastrointestinal surgery, a meta-analysis of 21 randomised controlled trials similarly affirmed the speedier recovery of gastrointestinal function after surgery when probiotics were administered (PMID: 35231076). In spite of these advantages, the routine use of probiotics perioperatively for colorectal cancer surgery is not performed in Singapore. We therefore seek to perform a trial to investigate whether probiotic administration perioperatively may reduce post operative ileus rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –Control arm with no nutritional supplementation |
| Arm 2 | Active comparator | Dietary Supplement: Nestle IsocalControl arm with nutritional supplementation but without probiotics |
| Arm 3 | Experimental | Dietary Supplement: Nestle Boost OptimumNutritional supplementation with probiotics |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- undergoing elective colorectal cancer surgery in which an oncologic resection is planned
- age between 21 and 99 years at the time of consent
- willing to consider oral nutritional supplementation
- on an early recovery after surgery (ERAS) pathway
- able to provide informed consent
Key exclusion criteria (5 listed)
- patients with known contraindications to probiotic use
- patients undergoing emergency surgery
- taking any other form of probiotics
- taking oral antibiotics within 7 days of commencement of study
- vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.
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 |
|---|---|---|
| Nestle IsocalNestle Isocal | Dietary supplement | Arm 2 |
| Nestle Boost OptimumNestle Boost Optimum | Dietary supplement | Arm 3 |
Primary outcome
Time to bowel movement
Time frame: 0 - 14 days
This records the number of days from the day of surgery before the first bowel movement was experienced by the patient.
4 secondary outcomes
Time to flatus
Time frame: 0 - 14 days
Adverse events
Time frame: From commencement of the intervention to 30 days after surgery
Infective complications
Time frame: From date of surgery to 30 days after surgery
Length of hospital stay
Time frame: 0 - 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 39972354Chan DKH, Siew BE, Lau J, Koh J, Lee MX, Ang C, Pang NQ, Tan KK. Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial. Trials. 2025 Feb 19;26(1):60. doi: 10.1186/s13063-025-08773-2.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nestle Isocal and Nestle Boost Optimum in people with Colorectal Cancer and Ileus Postoperative, run by National University Hospital, Singapore at 1 site in Singapore.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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 Singapore. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dedrick Chan, MBBS, DPhil (67795555, surckhd@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to bowel movement (time frame: 0 - 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456229, which also lists 1 linked publication.
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 Jun 2024.