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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06856434
Enrollment
50
Registered
2025-03-04
Start date
2025-08-01
Completion date
2026-09-30
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendectomy, Appendicitis With Perforation, Probiotic

Keywords

Perforated Appendicitis, Appendectomy, Probiotic, Laparotomy

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus plantarum sp Probiotic

Once daily consumption

OTHERPlacebo Group

Group who received a placebo intervention

Sponsors

Universitas Padjadjaran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
White Blood Cells LevelFrom the day of randomization up to 5 days postoperativelyA white blood count measures the number of white blood cells (WBCs) in patients' blood.

Secondary

MeasureTime frameDescription
Segmented Neutrophil levelFrom the day of randomization up to 5 days postoperativelySegmented neutrophils are the most mature neutrophilic granulocytes present in circulating blood
Post operative pain levelFrom the day of randomization up to 5 days postoperativelyThe 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 StayFrom the day of randomization up to 5 days postoperativelyThe duration of a single episode of hospitalization

Countries

Indonesia

Contacts

STUDY_DIRECTORReno Rudiman, Professor

Hasan Sadikin General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026