Clinical trial · Interventional
Influence of Probiotics Administration Before Liver Resection in Liver Disease
Circulating Endotoxemia After Liver Resection for Hepatocellular Carcinoma in Liver Disease - Influence of Preoperative Administration of Probiotics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surgical resection is one of the curative treatment modalities for HCC. Limits are postoperative septic and liver functional complications related to an increase in bacterial translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and bacterial degradation products from the intestine to the portal circulation. The endotoxemia secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO). NO is also a potent inducer of membrane instability, responsible for an increase in the permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a worsening of bacterial translocation. Probiotics are live microorganisms which when administered in adequate amounts, provide a health benefit on the host ((Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data from experimental and clinical literature show a significant effect of probiotics on the improvement of liver function and a decrease in infectious complications in patients with chronic liver disease. The proposed study would evaluate the effect preventive and therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic inflammation promotes postoperative complications.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Liver Fibrosis | — | UNRESOLVED | — |
| Permeability; Increased | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Probiotic | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo of Probiotics
- description
- Placebo: Composition: Each capsule contains 560 mg: * 459 mg of corn starch * 6 mg of magnesium stearate Dosage: 2 capsules / day, in the morning at sunrise, one at bedtime. Methods of administration: Oral. Duration of treatment: 14 days
- interventionNames
- Dietary Supplement: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Probiotics- Lactibiane Tolerance
- description
- Active substance mixture of lactic 10% Bifidobacterium lactis LA 303, 10% Lactobacillus acidophilus LA 201, LA 40% Lactobacillus plantarum 301, 20% Lactobacillus salivarius LA 302, LA 20% Bifidobacterium lactis 304 Dosage: 10 X 10\^9 probiotic / capsule Composition: One capsule of 560 mg contains Lactibiane tolerance: * 345 mg of corn starch * 114 mg premix lactic * 6 mg of magnesium stearate Excipients: magnesium stearate Method of administration: Oral Dosage: 2 capsules per day for 14 days in two doses: one capsule at sunrise, one capsule at bedtime;
- interventionNames
- Dietary Supplement: Probiotic
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Agreement signed by the patient * Diagnosis of HCC confirmed * Diagnosis of liver disease (score F3 or F4) confirmed * Indication of surgical resection confirmed and validated by a specialist multidisciplinary assessment meeting of gastrointestinal oncology * Patient operable (no indication against anaesthesiological) * Resectable tumor lesion (surgical expertise) * Laboratory tests and endoscopy: No suspicion of severe portal hypertension with bleeding risk Exclusion Criteria: * Patient not willing, at risk of default of compliance, or patient can not be monitored regularly * Antibiotic extended or terminated for less than 1 month, may limit the effects of taking probiotics. * Inflammatory Bowel Disease, which could skew the results expected by taking probiotics results.
References
Publications (1)
- DERIVEDRoussel E, Brasse-Lagnel C, Tuech JJ, Montialoux H, Papet E, Tortajada P, Bekri S, Schwarz L. Influence of Probiotics Administration Before Liver Resection in Patients with Liver Disease: A Randomized Controlled Trial. World J Surg. 2022 Mar;46(3):656-665. doi: 10.1007/s00268-021-06388-7. Epub 2021 Nov 26. PMID 34837121