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RecruitingNCT06456229PICCS-1Updated Jun 13, 2024

Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery

An interventional study of Nestle Isocal and Nestle Boost Optimum in Colorectal Cancer, Ileus Postoperative and Flatus, sponsored by National University Hospital, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
21 Years to 99 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • 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
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 162 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. undergoing elective colorectal cancer surgery in which an oncologic resection is planned
  2. age between 21 and 99 years at the time of consent
  3. willing to consider oral nutritional supplementation
  4. on an early recovery after surgery (ERAS) pathway
  5. able to provide informed consent

Exclusion criteria

Exclusion Criteria:

  1. patients with known contraindications to probiotic use
  2. patients undergoing emergency surgery
  3. taking any other form of probiotics
  4. taking oral antibiotics within 7 days of commencement of study
  5. vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • No intervention
    Arm 1

    Control arm with no nutritional supplementation

  • Active comparator
    Arm 2

    Control arm with nutritional supplementation but without probiotics

    Dietary Supplement: Nestle Isocal

  • Experimental
    Arm 3

    Nutritional supplementation with probiotics

    Dietary Supplement: Nestle Boost Optimum

Interventions

  • Dietary supplementNestle Isocal

    Nestle Isocal

  • Dietary supplementNestle Boost Optimum

    Nestle Boost Optimum

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 - 14 days

Secondary outcomes

  1. Time to flatus

    This records the number of days from the day of surgery before the first flatus was experienced by the patient.

    Time frame: 0 - 14 days

  2. Adverse events

    Any adverse events related to the intervention. This comprises predominantly gastrointestinal related complications

    Time frame: From commencement of the intervention to 30 days after surgery

  3. Infective complications

    Any infective complications which may occur in the postoperative period.

    Time frame: From date of surgery to 30 days after surgery

  4. Length of hospital stay

    This records the number of days following surgery before the patient is discharged.

    Time frame: 0 - 14 days

07

Study locations

1 of 1 sites recruiting
  • National University Hospital
    Singapore, 119074, Singapore
    • Dedrick Chan, MBBS, DPhil · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06456229
Lead sponsor
National University Hospital, Singapore
Responsible party
Sponsor
First posted
Jun 13, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Jun 13, 2024

Study contacts

Dedrick Chan, MBBS, DPhil
Contact
surckhd@nus.edu.sg
67795555

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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