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

NCT ID: NCT06856434

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis with Perforation Appendectomy Probiotic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic Group

Patient with perforated appendicitis who received an intervention

Group Type EXPERIMENTAL

Lactobacillus plantarum sp Probiotic

Intervention Type DIETARY_SUPPLEMENT

Once daily consumption

Placebo Group

Patients with perforated appendicitis who did not receive an intervention

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type OTHER

Group who received a placebo intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus plantarum sp Probiotic

Once daily consumption

Intervention Type DIETARY_SUPPLEMENT

Placebo Group

Group who received a placebo intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitas Padjadjaran

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ricarhdo Valentino Hanafi, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ricarhdo Valentino Hanafi, MD

Role: CONTACT

+628111951997

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36814190 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SURG-202407.01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Probiotics and Recovery From Surgery
NCT01970683 TERMINATED PHASE3