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OpenTrials
Active, Not Recruiting

NCT Number: NCT06856434

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Appendicitis With Perforation Appendectomy Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Probiotic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus plantarum sp Probiotic

Dietary Supplement

Once daily consumption

Placebo Group

Other

Group who received a placebo intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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'

  3. Length of Hospital Stay

    Time frame: From the day of randomization up to 5 days postoperatively

    The duration of a single episode of hospitalization

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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