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

Early Phase 1

Not yet recruiting

• Conditions: Appendicitis with Perforation; Appendectomy; Probiotic

• Registration Number: NCT06856434
• Lead Sponsor: Universitas Padjadjaran

Brief Summary

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?

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
White Blood Cells Level	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.

Secondary Outcome Measures

Name	Time	Method
Segmented Neutrophil level	From the day of randomization up to 5 days postoperatively	Segmented neutrophils are the most mature neutrophilic granulocytes present in circulating blood
Post operative pain level	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'
Length of Hospital Stay	From the day of randomization up to 5 days postoperatively	The duration of a single episode of hospitalization