NCT06856434

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?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

February 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 31, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 20, 2025

Last Update Submit

March 25, 2026

Conditions

Appendicitis With PerforationAppendectomyProbiotic

Keywords

Perforated AppendicitisAppendectomyProbioticLaparotomy

Outcome Measures

Primary Outcomes (1)

  • White Blood Cells Level

    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 Outcomes (3)

  • Segmented Neutrophil level

    From the day of randomization up to 5 days postoperatively

  • Post operative pain level

    From the day of randomization up to 5 days postoperatively

  • Length of Hospital Stay

    From the day of randomization up to 5 days postoperatively

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Patient with perforated appendicitis who received an intervention

Dietary Supplement: Lactobacillus plantarum sp Probiotic

Placebo Group

PLACEBO COMPARATOR

Patients with perforated appendicitis who did not receive an intervention

Other: Placebo Group

Interventions

Lactobacillus plantarum sp ProbioticDIETARY_SUPPLEMENT

Once daily consumption

Probiotic Group
Placebo GroupOTHER

Group who received a placebo intervention

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

Related Publications (1)

  • Guan L, Liu Z, Pan G, Zhang B, Wu Y, Gan T, Ouyang G. The global, regional, and national burden of appendicitis in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. BMC Gastroenterol. 2023 Feb 22;23(1):44. doi: 10.1186/s12876-023-02678-7.

    PMID: 36814190RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Reno Rudiman, Professor

    Hasan Sadikin General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 4, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 31, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All data will be available for public

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The full data protocol will be available immediately after publication
Access Criteria
No specific criteria. Available for all readers

Locations

ID(1)