Colorectal CancerPhase 4NCT07144475
Comparison of Probiotic Effects on the Outcomes of Patients After Colorectal Cancer Surgery
A Phase 4 study testing Lactobacillus casei Shirota and Lactobacillus acidophilus in people with Colorectal Cancer, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
Trial summary
This clinical trial aims to compare the effects of administering Lactobacillus casei Shirota probiotics with Lactobacillus acidophilus on the outcomes of patients after colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Lactobacillus casei Shirota and Lactobacillus acidophilus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 4 Mar 2025
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients who were diagnosed with colorectal cancer and would undergo resection surgery at Dharmais Cancer Hospital
Who cannot join
- The patient or patient's family refused to be included in the study
- Patients with chronic diseases such as HIV, uncontrolled diabetes mellitus (, uncontrolled cardiovascular disease and kidney failure
- Patients with a history of regular probiotics, or steroids, or antibiotics consumption
- Patients with anatomical disorders of the gastrointestinal system
- Patients with immunocompromised conditions.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, 10430
About this study
Official title: Comparison of Probiotic Effects of Lactobacillus Casei Shirota With Lactobacillus Acidophilus on the Outcomes of Patients After Colorectal Cancer Surgery: A Study of Gastrointestinal Function, Sepsis Incidence, C-Reactive Protein, Interleukin 6 and Length of Stay
This clinical trial aims to compare the effects of administering Lactobacillus casei Shirota probiotics with Lactobacillus acidophilus on the outcomes of patients after colorectal cancer surgery. Researchers will compare probiotic to see if Lactobacillus casei Shirota improves gastrointestinal function, sepsis incidence, C-reactive protein (CRP), interleukin 6 (IL-6), and length of stay better than Lactobacillus acidophilus. Participants will take probiotics three times daily for three days before surgery.
Read the detailed description
The research design was a two-group unblinded, randomized clinical trial in 90 adult patients undergoing colorectal cancer surgery who are treated in the ICU, HCU and wards of Dharmais Cancer Hospital. Subjects who meet the criteria are divided into 2 (two) groups: the group given Lactobacillus casei Shirota and Lactobacillus acidophilus probiotics. Assessment of gastrointestinal function using the I-FEED score for early feeding was carried out on the second day after surgery. Sepsis diagnosis used the NEWS2 scoring assessed on the second, fourth, and sixth days of treatment. CRP levels were measured three times, namely during perioperative visit before surgery, four hours before surgery and three days after surgery. IL-6 levels were measured twice, namely perioperative visit before surgery and three days after surgery. Length of stay was calculated from after surgery until the patient was discharged.
- Conditions
- Colorectal Cancer
- Being tested
- Lactobacillus casei Shirota, Lactobacillus acidophilus
- Keywords
- Probiotics, Lactobacillus casei Shirota, Lactobacillus acidophilus, Colorectal cancer, Surgical outcomes
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei ShirotaBiological
Also called Yakult Light
Consumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Lactobacillus acidophilusBiological
Also called Natrol Acidophilus Probiotic
Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus casei Shirota Group | Active comparator | Participants were given probiotic liquid beverage containing 6,5x10^9 CFU of Lactobacillus casei Shirota strain Receives: Biological: Lactobacillus casei Shirota |
| Lactobacillus acidophilus Group | Active comparator | Participants were given Probiotic capsule containing 10^9 CFU of Lactobacillus acidophilus strain Receives: Biological: Lactobacillus acidophilus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Function
Assessed using I-FEED score which measures postoperative gastrointestinal function that contains five elements (intake, response to nausea treatment, emesis, examination, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)
Measured: Second day of treatment in the ICU
Sepsis Incidence
Assessed using NEWS2 to determine patient's degree of illness and prompts critical care intervention
Measured: second, fourth, and sixth days of treatment
C-reactive protein (CRP)
CRP is a protein synthesized in the liver and will increase in response to inflammation. Baseline CRP data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption
Measured: Baseline, four hours before surgery and three days after surgery
Interleukin 6 (IL-6)
IL-6 is a soluble mediator that has several functions in the immune response. IL-6 is produced in response to infection or tissue trauma. Baseline IL-6 data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption.
Measured: Baseline and three days after surgery
Length of stay
The number of days of patient care after undergoing colorectal cancer surgery until the patient can be treated as an outpatient
Measured: Up to 16 days (documented maximum length of stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Nov 2024
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dharmais National Cancer Center Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berial Dewin Marzaini, Dharmais National Cancer Center Hospital
- Investigators
- Berial D Marzaini, MD, Principal investigator, Faculty of Medicine, University of IndonesiaDita Aditianingsih, Professor, Study chair, Faculty of Medicine, University of IndonesiaArif HM Marsaban, MD, Study chair, Faculty of Medicine, University of IndonesiaGardian L Hakim, MD, Study chair, Dharmais Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144475
- Sponsor's protocol ID
- DP.04.03/11.7/020/2024
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arumugam S, Lau CS, Chamberlain RS. Probiotics and Synbiotics Decrease Postoperative Sepsis in Elective Gastrointestinal Surgical Patients: a Meta-Analysis. J Gastrointest Surg. 2016 Jun;20(6):1123-31. doi: 10.1007/s11605-016-3142-y. Epub 2016 Apr 12.
PubMed 27073082Khailova L, Frank DN, Dominguez JA, Wischmeyer PE. Probiotic administration reduces mortality and improves intestinal epithelial homeostasis in experimental sepsis. Anesthesiology. 2013 Jul;119(1):166-77. doi: 10.1097/ALN.0b013e318291c2fc.
PubMed 23571641Mulita F, Liolis E, Akinosoglou K, Tchabashvili L, Maroulis I, Kaplanis C, Vailas M, Panos G. Postoperative sepsis after colorectal surgery: a prospective single-center observational study and review of the literature. Prz Gastroenterol. 2022;17(1):47-51. doi: 10.5114/pg.2021.106083. Epub 2021 May 23.
PubMed 35371356Bai Y, Huang Y, Li Y, Zhang B, Xiao C, Hou X, Yu L. The Murine Reg3a Stimulated by Lactobacillus casei Promotes Intestinal Cell Proliferation and Inhibits the Multiplication of Porcine Diarrhea Causative Agent in vitro. Front Microbiol. 2021 Jun 18;12:675263. doi: 10.3389/fmicb.2021.675263. eCollection 2021.
PubMed 34220758Pak H, Maghsoudi LH, Soltanian A, Gholami F. Surgical complications in colorectal cancer patients. Ann Med Surg (Lond). 2020 May 11;55:13-18. doi: 10.1016/j.amsu.2020.04.024. eCollection 2020 Jul.
PubMed 32435475Shida K, Kiyoshima-Shibata J, Nagaoka M, Watanabe K, Nanno M. Induction of interleukin-12 by Lactobacillus strains having a rigid cell wall resistant to intracellular digestion. J Dairy Sci. 2006 Sep;89(9):3306-17. doi: 10.3168/jds.S0022-0302(06)72367-0.
PubMed 16899663Alsharqawi N, Alhashemi M, Kaneva P, Baldini G, Fiore JF Jr, Feldman LS, Lee L. Validity of the I-FEED score for postoperative gastrointestinal function in patients undergoing colorectal surgery. Surg Endosc. 2020 May;34(5):2219-2226. doi: 10.1007/s00464-019-07011-6. Epub 2019 Jul 30.
PubMed 31363895Tan CK, Said S, Rajandram R, Wang Z, Roslani AC, Chin KF. Pre-surgical Administration of Microbial Cell Preparation in Colorectal Cancer Patients: A Randomized Controlled Trial. World J Surg. 2016 Aug;40(8):1985-92. doi: 10.1007/s00268-016-3499-9.
PubMed 27098538Pitsillides L, Pellino G, Tekkis P, Kontovounisios C. The Effect of Perioperative Administration of Probiotics on Colorectal Cancer Surgery Outcomes. Nutrients. 2021 Apr 25;13(5):1451. doi: 10.3390/nu13051451.
PubMed 33922897Qin D, Ma Y, Wang Y, Hou X, Yu L. Contribution of Lactobacilli on Intestinal Mucosal Barrier and Diseases: Perspectives and Challenges of Lactobacillus casei. Life (Basel). 2022 Nov 16;12(11):1910. doi: 10.3390/life12111910.
PubMed 36431045Dempsey E, Corr SC. Lactobacillus spp. for Gastrointestinal Health: Current and Future Perspectives. Front Immunol. 2022 Apr 6;13:840245. doi: 10.3389/fimmu.2022.840245. eCollection 2022.
PubMed 35464397
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Probiotic Effects of Lactobacillus Casei Shirota With Lactobacillus Acidophilus on the Outcomes of Patients After Colorectal Cancer Surgery: A Study of Gastrointestinal Function, Sepsis Incidence, C-Reactive Protein, Interleukin 6 and Length of Stay
- ClinicalTrials.gov ID
- NCT07144475
- Acronym / sponsor ID
- DP.04.03/11.7/020/2024
- Conditions
- Colorectal Cancer
- Keywords
- Probiotics, Lactobacillus casei Shirota, Lactobacillus acidophilus, Colorectal cancer, Surgical outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dharmais National Cancer Center HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 27 Aug 2025 (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.
This clinical trial aims to compare the effects of administering Lactobacillus casei Shirota probiotics with Lactobacillus acidophilus on the outcomes of patients after colorectal cancer surgery. Researchers will compare probiotic to see if Lactobacillus casei Shirota improves gastrointestinal function, sepsis incidence, C-reactive protein (CRP), interleukin 6 (IL-6), and length of stay better than Lactobacillus acidophilus. Participants will take probiotics three times daily for three days before surgery.
Detailed description
The research design was a two-group unblinded, randomized clinical trial in 90 adult patients undergoing colorectal cancer surgery who are treated in the ICU, HCU and wards of Dharmais Cancer Hospital. Subjects who meet the criteria are divided into 2 (two) groups: the group given Lactobacillus casei Shirota and Lactobacillus acidophilus probiotics. Assessment of gastrointestinal function using the I-FEED score for early feeding was carried out on the second day after surgery. Sepsis diagnosis used the NEWS2 scoring assessed on the second, fourth, and sixth days of treatment. CRP levels were measured three times, namely during perioperative visit before surgery, four hours before surgery and three days after surgery. IL-6 levels were measured twice, namely perioperative visit before surgery and three days after surgery. Length of stay was calculated from after surgery until the patient was discharged.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus casei Shirota Group | Active comparator | Biological: Lactobacillus casei ShirotaParticipants were given probiotic liquid beverage containing 6,5x10^9 CFU of Lactobacillus casei Shirota strain |
| Lactobacillus acidophilus Group | Active comparator | Biological: Lactobacillus acidophilusParticipants were given Probiotic capsule containing 10^9 CFU of Lactobacillus acidophilus strain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients who were diagnosed with colorectal cancer and would undergo resection surgery at Dharmais Cancer Hospital
Key exclusion criteria (5 listed)
- The patient or patient's family refused to be included in the study
- Patients with chronic diseases such as HIV, uncontrolled diabetes mellitus (, uncontrolled cardiovascular disease and kidney failure
- Patients with a history of regular probiotics, or steroids, or antibiotics consumption
- Patients with anatomical disorders of the gastrointestinal system
- Patients with immunocompromised conditions.
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 |
|---|---|---|
| Lactobacillus casei ShirotaAlso: Yakult LightConsumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM. | Biological | Lactobacillus casei Shirota Group |
| Lactobacillus acidophilusAlso: Natrol Acidophilus ProbioticConsumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM. | Biological | Lactobacillus acidophilus Group |
Primary outcome
Gastrointestinal Function
Time frame: Second day of treatment in the ICU
Assessed using I-FEED score which measures postoperative gastrointestinal function that contains five elements (intake, response to nausea treatment, emesis, examination, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)
Sepsis Incidence
Time frame: second, fourth, and sixth days of treatment
Assessed using NEWS2 to determine patient's degree of illness and prompts critical care intervention
C-reactive protein (CRP)
Time frame: Baseline, four hours before surgery and three days after surgery
CRP is a protein synthesized in the liver and will increase in response to inflammation. Baseline CRP data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption
Interleukin 6 (IL-6)
Time frame: Baseline and three days after surgery
IL-6 is a soluble mediator that has several functions in the immune response. IL-6 is produced in response to infection or tissue trauma. Baseline IL-6 data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption.
Length of stay
Time frame: Up to 16 days (documented maximum length of stay)
The number of days of patient care after undergoing colorectal cancer surgery until the patient can be treated as an outpatient
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 27 Aug 2025.
- Background: PubMed 27073082Arumugam S, Lau CS, Chamberlain RS. Probiotics and Synbiotics Decrease Postoperative Sepsis in Elective Gastrointestinal Surgical Patients: a Meta-Analysis. J Gastrointest Surg. 2016 Jun;20(6):1123-31. doi: 10.1007/s11605-016-3142-y. Epub 2016 Apr 12.
- Background: PubMed 23571641Khailova L, Frank DN, Dominguez JA, Wischmeyer PE. Probiotic administration reduces mortality and improves intestinal epithelial homeostasis in experimental sepsis. Anesthesiology. 2013 Jul;119(1):166-77. doi: 10.1097/ALN.0b013e318291c2fc.
- Background: PubMed 35371356Mulita F, Liolis E, Akinosoglou K, Tchabashvili L, Maroulis I, Kaplanis C, Vailas M, Panos G. Postoperative sepsis after colorectal surgery: a prospective single-center observational study and review of the literature. Prz Gastroenterol. 2022;17(1):47-51. doi: 10.5114/pg.2021.106083. Epub 2021 May 23.
- Background: PubMed 34220758Bai Y, Huang Y, Li Y, Zhang B, Xiao C, Hou X, Yu L. The Murine Reg3a Stimulated by Lactobacillus casei Promotes Intestinal Cell Proliferation and Inhibits the Multiplication of Porcine Diarrhea Causative Agent in vitro. Front Microbiol. 2021 Jun 18;12:675263. doi: 10.3389/fmicb.2021.675263. eCollection 2021.
- Background: PubMed 32435475Pak H, Maghsoudi LH, Soltanian A, Gholami F. Surgical complications in colorectal cancer patients. Ann Med Surg (Lond). 2020 May 11;55:13-18. doi: 10.1016/j.amsu.2020.04.024. eCollection 2020 Jul.
- Background: PubMed 16899663Shida K, Kiyoshima-Shibata J, Nagaoka M, Watanabe K, Nanno M. Induction of interleukin-12 by Lactobacillus strains having a rigid cell wall resistant to intracellular digestion. J Dairy Sci. 2006 Sep;89(9):3306-17. doi: 10.3168/jds.S0022-0302(06)72367-0.
- Background: PubMed 31363895Alsharqawi N, Alhashemi M, Kaneva P, Baldini G, Fiore JF Jr, Feldman LS, Lee L. Validity of the I-FEED score for postoperative gastrointestinal function in patients undergoing colorectal surgery. Surg Endosc. 2020 May;34(5):2219-2226. doi: 10.1007/s00464-019-07011-6. Epub 2019 Jul 30.
- Background: PubMed 27098538Tan CK, Said S, Rajandram R, Wang Z, Roslani AC, Chin KF. Pre-surgical Administration of Microbial Cell Preparation in Colorectal Cancer Patients: A Randomized Controlled Trial. World J Surg. 2016 Aug;40(8):1985-92. doi: 10.1007/s00268-016-3499-9.
- Background: PubMed 33922897Pitsillides L, Pellino G, Tekkis P, Kontovounisios C. The Effect of Perioperative Administration of Probiotics on Colorectal Cancer Surgery Outcomes. Nutrients. 2021 Apr 25;13(5):1451. doi: 10.3390/nu13051451.
- Background: PubMed 36431045Qin D, Ma Y, Wang Y, Hou X, Yu L. Contribution of Lactobacilli on Intestinal Mucosal Barrier and Diseases: Perspectives and Challenges of Lactobacillus casei. Life (Basel). 2022 Nov 16;12(11):1910. doi: 10.3390/life12111910.
- Background: PubMed 35464397Dempsey E, Corr SC. Lactobacillus spp. for Gastrointestinal Health: Current and Future Perspectives. Front Immunol. 2022 Apr 6;13:840245. doi: 10.3389/fimmu.2022.840245. eCollection 2022.
- 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.
Berial D Marzaini, MD principal investigator
Faculty of Medicine, University of Indonesia
Dita Aditianingsih, Professor study chair
Faculty of Medicine, University of Indonesia
Arif HM Marsaban, MD study chair
Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus casei Shirota and Lactobacillus acidophilus in people with Colorectal Cancer, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
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 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: finished, as of the sponsor's last update on 27 Aug 2025. 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 Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gastrointestinal Function (time frame: Second day of treatment in the ICU). The study lists 5 primary outcomes in all. 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 NCT07144475, which also lists 11 linked publications.
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 27 Aug 2025.