Bacterial Translocation Markers as Predictors of Infectious and Inflammatory Complications in Acute Bowel Obstruction

NCT05229822 | Completed Results

• 1 other identifier: BT-ABO
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Despite modern approaches to the diagnosis and treatment of acute bowel obstruction (ABO), postoperative mortality ranges from 5 to 32%, and complications occur up 23% of cases. One of the formidable infectious and inflammatory complications of ABO is sepsis. The main component of the development of sepsis in ABO is bacterial translocation (BT). BT is the migration of intestinal bacteria or their products through the intestinal mucosa into the mesenteric lymph nodes and further into normally sterile tissues and organs. Today there are several methods for detecting BT:

1. 1.direct method - the detection of 16s rRNA (ribosomal ribonucleic acid) in mesenteric lymph nodes (MLN);
2. 2.indirect method - the detection of serum lipopolysaccharide-binding protein (LBP) and presepsin (Soluble CD14 subtype or sCD14-ST).

Conditions

Intestinal Obstruction; Colorectal Cancer; Post-Op Complication; Systemic Inflammatory Response Syndrome; Colon Tumor

Keywords

acute bowel obstruction; colon tumor; bacterial translocation; presepsin; lipopolysaccharide-binding protein; 16s rRNA; post-operative complications

Outcome Measures

Primary Outcomes (1)

• Change in Number of Participants With Post-operative Infectious and Inflammatory Complications

  Аny infectious and inflammatory complications in post-operative period (wound suppuration, anastomotic leak, аbdominal abscesses, peritonitis, sepsis, etc.)

  Once (if any complication occurs during hospitalization - from 7 to 28 days)

Secondary Outcomes (3)

• LBP Level in Serum Blood

  1 hour before surgery, 72 hours after surgery

• sCD14-ST Level in Serum Blood

  1 hour before surgery, 72 hours after surgery

• 16s rRNA in Mesenteric Lymph Nodes

  Once (MLN sampling in sterile conditions during surgery)

Study Arms (3)

Malignant ABO

60 patients with malignant acute bowel obstruction

Diagnostic Test: LBP; Diagnostic Test: sCD14-ST; Diagnostic Test: 16s rRNA

CRC without ABO (control)

60 colorectal cancer patients without acute bowel obstruction (planned operations)

Diagnostic Test: LBP; Diagnostic Test: sCD14-ST; Diagnostic Test: 16s rRNA

Benign ABO

30 patients with benign acute bowel obstruction

Diagnostic Test: LBP; Diagnostic Test: sCD14-ST; Diagnostic Test: 16s rRNA

Interventions

LBP DIAGNOSTIC_TEST

Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.

Benign ABO; CRC without ABO (control); Malignant ABO

sCD14-ST DIAGNOSTIC_TEST

Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.

Benign ABO; CRC without ABO (control); Malignant ABO

16s rRNA DIAGNOSTIC_TEST

Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.

Benign ABO; CRC without ABO (control); Malignant ABO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with malignant and benign acute bowel obstruction, colorectal cancer patients without acute bowel obstruction (planned operations) aged from 18, who are expected to undergo surgical treatment for this pathology.

You may qualify if:

• patients with malignant acute bowel obstruction,
• patients with benign acute bowel obstruction,
• colorectal cancer patients without acute bowel obstruction (planned operations).

You may not qualify if:

• age less than 18,
• pregnancy,
• patients with paralytic acute bowel obstruction,
• patients with HIV infection, liver cirrhosis,
• patient with an infectious process due to another pathology.

Sponsors & Collaborators

• Karaganda Medical University: lead
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

Study Sites (1)

NJSC Karaganda Medical University

Karaganda, 100000, Kazakhstan

Location

Related Publications (19)

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• Chiu HC, Lin YC, Hsieh HM, Chen HP, Wang HL, Wang JY. The impact of complications on prolonged length of hospital stay after resection in colorectal cancer: A retrospective study of Taiwanese patients. J Int Med Res. 2017 Apr;45(2):691-705. doi: 10.1177/0300060516684087. Epub 2017 Feb 7.

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  PMID: 16288452 BACKGROUND

• Fang L, Xu Z, Wang GS, Ji FY, Mei CX, Liu J, Wu GM. Directed evolution of an LBP/CD14 inhibitory peptide and its anti-endotoxin activity. PLoS One. 2014 Jul 15;9(7):e101406. doi: 10.1371/journal.pone.0101406. eCollection 2014.

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• Stehle JR Jr, Leng X, Kitzman DW, Nicklas BJ, Kritchevsky SB, High KP. Lipopolysaccharide-binding protein, a surrogate marker of microbial translocation, is associated with physical function in healthy older adults. J Gerontol A Biol Sci Med Sci. 2012 Nov;67(11):1212-8. doi: 10.1093/gerona/gls178. Epub 2012 Sep 7.

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• Kell DB, Pretorius E. On the translocation of bacteria and their lipopolysaccharides between blood and peripheral locations in chronic, inflammatory diseases: the central roles of LPS and LPS-induced cell death. Integr Biol (Camb). 2015 Nov;7(11):1339-77. doi: 10.1039/c5ib00158g.

  PMID: 26345428 BACKGROUND

• Mussap M, Noto A, Fravega M, Fanos V. Soluble CD14 subtype presepsin (sCD14-ST) and lipopolysaccharide binding protein (LBP) in neonatal sepsis: new clinical and analytical perspectives for two old biomarkers. J Matern Fetal Neonatal Med. 2011 Oct;24 Suppl 2:12-4. doi: 10.3109/14767058.2011.601923.

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• van Maldeghem I, Nusman CM, Visser DH. Soluble CD14 subtype (sCD14-ST) as biomarker in neonatal early-onset sepsis and late-onset sepsis: a systematic review and meta-analysis. BMC Immunol. 2019 Jun 3;20(1):17. doi: 10.1186/s12865-019-0298-8.

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• Hosomi S, Yamagami H, Itani S, Yukawa T, Otani K, Nagami Y, Tanaka F, Taira K, Kamata N, Tanigawa T, Shiba M, Watanabe T, Fujiwara Y. Sepsis Markers Soluble IL-2 Receptor and Soluble CD14 Subtype as Potential Biomarkers for Complete Mucosal Healing in Patients With Inflammatory Bowel Disease. J Crohns Colitis. 2018 Jan 5;12(1):87-95. doi: 10.1093/ecco-jcc/jjx124.

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Related Links

• Mierzchala M, Krzystek-Korpacka M, Gamian A, Durek G. Quantitative indices of dynamics in concentrations of lipopolysaccharide-binding protein (LBP) as prognostic factors in severe sepsis/septic shock patients - Comparison with CRP and procalcitonin /
• Masson S, Caironi P, Fanizza C, Thomae R, Bernasconi R, Noto A, Oggioni R, Pasetti GS, Romero M, Tognoni G, Latini R, Gattinoni L. Circulating presepsin (soluble CD14 subtype) as a marker of host response in patients with severe sepsis or septic shock

MeSH Terms

Conditions

Intestinal Obstruction; Colorectal Neoplasms; Postoperative Complications; Systemic Inflammatory Response Syndrome; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Shock

Results Point of Contact

• Title: Dr. Yermek Turguov
• Organization: NJSC KARAGANDA MEDICAL UNIVERSITY

Turgunov@qmu.kz

+77016119655

Study Officials

• Yemek Turgunov, Pr.

  NJSC Karaganda Medical University

  STUDY CHAIR

• Alina Ogizbayeva, PhD student

  NJSC Karaganda Medical University

  PRINCIPAL INVESTIGATOR

• Lyudmila Akhmaltdinova, PhD

  NJSC Karaganda Medical University

  PRINCIPAL INVESTIGATOR

• Kairat Shakeyev, Pr.

  NJSC Karaganda Medical University

  PRINCIPAL INVESTIGATOR

• Dmitry Matyushko, PhD

  Multidisciplinary hospital No. 1 of Karaganda

  PRINCIPAL INVESTIGATOR

• Miras Mugazov, PhD

  NJSC Karaganda Medical University

  PRINCIPAL INVESTIGATOR

• Asylbek Zhumakaev, Master

  Multidisciplinary hospital No. 3 of Karaganda

  PRINCIPAL INVESTIGATOR

• Irina Kadyrova, PhD

  NJSC Karaganda Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 8, 2022
• Study Start: March 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)