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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus casei Shirota Group | Active Comparator | Participants were given probiotic liquid beverage containing 6,5x10^9 CFU of Lactobacillus casei Shirota strain |
|
| Lactobacillus acidophilus Group | Active Comparator | Participants were given Probiotic capsule containing 10^9 CFU of Lactobacillus acidophilus strain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus casei Shirota | Biological | Consumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Second day of treatment in the ICU |
| Sepsis Incidence | Assessed using NEWS2 to determine patient's degree of illness and prompts critical care intervention | 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 | 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. | 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 | Up to 16 days (documented maximum length of stay) |
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Inclusion Criteria:
1. Patients who were diagnosed with colorectal cancer and would undergo resection surgery at Dharmais Cancer Hospital
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berial D Marzaini, MD | Faculty of Medicine, University of Indonesia | Principal Investigator |
| Dita Aditianingsih, Professor | Faculty of Medicine, University of Indonesia | Study Chair |
| Arif HM Marsaban, MD | Faculty of Medicine, University of Indonesia | Study Chair |
| Gardian L Hakim, MD | Dharmais Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, University of Indonesia | Jakarta | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27073082 | Background | 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. | |
| 23571641 | Background | Khailova 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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|
| Lactobacillus acidophilus | Biological | Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM. |
|
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| 35371356 | Background | Mulita 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. |
| 34220758 | Background | Bai 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. |
| 32435475 | Background | Pak 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. |
| 16899663 | Background | Shida 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. |
| 31363895 | Background | Alsharqawi 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. |
| 27098538 | Background | Tan 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. |
| 33922897 | Background | Pitsillides 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. |
| 36431045 | Background | Qin 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. |
| 35464397 | Background | Dempsey 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |