Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis

March 25, 2026 updated by: Ricarhdo Valentino Hanafi, MD, Universitas Padjadjaran

Effect of Lactobacillus Plantarum Probiotics on Inflammation and Postoperative Complications in Patients With Diffuse Peritonitis Due to Perforated Appendicitis After Laparotomy Appendectomy: A Randomized Controlled Trial

Does the administration of the probiotic Lactobacillus plantarum sp. have an impact on reducing leukocyte levels, segmented neutrophil counts, postoperative pain, and length of hospitalization in patients with diffuse peritonitis caused by perforated acute appendicitis who underwent laparotomy appendectomy at Dr. Hasan Sadikin Hospital?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

To determine whether the administration of the probiotic Lactobacillus plantarum sp. to patients with diffuse peritonitis caused by appendiceal perforation undergoing laparotomy appendectomy at Hasan Sadikin Hospital Bandung and Siloam Karawaci Hospital has a significant effect on leukocyte levels, segmented neutrophil counts, postoperative pain levels, and length of hospitalization compared to the placebo group.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Hasan Sadikin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with diffuse peritonitis caused by appendicitis
  • Patients undergoing laparotomic appendectomy.
  • Patients aged 18 years or older.

Exclusion Criteria:

  • Patients with a history of previous laparotomy.
  • Patients who underwent laparotomy combined with surgery on other parts of the body.
  • Patients with a history of cancer.
  • Patients with pre-existing comorbidities (uncontrolled diabetes mellitus, congestive heart failure, end-stage renal disease [ESRD], human immunodeficiency virus [HIV], and systemic lupus erythematosus [SLE]).
  • Patients with multiple organ dysfunction syndrome (MODS).
  • Patients with prior consumption of probiotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic Group
Patient with perforated appendicitis who received an intervention
Dietary supplement: Lactobacillus plantarum sp Probiotic
Once daily consumption
Placebo Comparator: Placebo Group
Patients with perforated appendicitis who did not receive an intervention
Other: Placebo Group
Group who received a placebo intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White Blood Cells Level
Time Frame: From the day of randomization up to 5 days postoperatively
A white blood count measures the number of white blood cells (WBCs) in patients' blood.
From the day of randomization up to 5 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Segmented Neutrophil level
Time Frame: From the day of randomization up to 5 days postoperatively
Segmented neutrophils are the most mature neutrophilic granulocytes present in circulating blood
From the day of randomization up to 5 days postoperatively
Post operative pain level
Time Frame: From the day of randomization up to 5 days postoperatively
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'
From the day of randomization up to 5 days postoperatively
Length of Hospital Stay
Time Frame: From the day of randomization up to 5 days postoperatively
The duration of a single episode of hospitalization
From the day of randomization up to 5 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Study Director: Reno Rudiman, Professor, Hasan Sadikin General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURG-202407.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available for public

IPD Sharing Time Frame

The full data protocol will be available immediately after publication

IPD Sharing Access Criteria

No specific criteria. Available for all readers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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