Appendicitis With PerforationNCT06856434
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
A study testing Lactobacillus plantarum sp Probiotic in people with Appendicitis With Perforation and Appendectomy, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis With Perforation, Appendectomy, Probiotic
- What is being tested?
- Lactobacillus plantarum sp Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with diffuse peritonitis caused by appendicitis
- Patients undergoing laparotomic appendectomy.
- Patients aged 18 years or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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?
Read the 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.
- Conditions
- Appendicitis With Perforation, Appendectomy, Probiotic
- Being tested
- Lactobacillus plantarum sp Probiotic, Placebo Group
- Keywords
- Perforated Appendicitis, Appendectomy, Probiotic, Laparotomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum sp ProbioticDietary supplement
Once daily consumption
Placebo GroupOther
Group who received a placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Patient with perforated appendicitis who received an intervention Receives: Dietary Supplement: Lactobacillus plantarum sp Probiotic |
| Placebo Group | Placebo comparator | Patients with perforated appendicitis who did not receive an intervention Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Blood Cells Level
A white blood count measures the number of white blood cells (WBCs) in patients' blood.
Measured: From the day of randomization up to 5 days postoperatively
Secondary outcomes (3)
Segmented Neutrophil level
Segmented neutrophils are the most mature neutrophilic granulocytes present in circulating blood
Measured: From the day of randomization up to 5 days postoperatively
Post operative pain level
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'
Measured: From the day of randomization up to 5 days postoperatively
Length of Hospital Stay
The duration of a single episode of hospitalization
Measured: From the day of randomization up to 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appendicitis With PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricarhdo Valentino Hanafi, MD, Universitas Padjadjaran
- Investigators
- Reno Rudiman, Professor, Study director, Hasan Sadikin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856434
- Sponsor's protocol ID
- SURG-202407.01
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available for public
Publications
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.
PubMed 36814190
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06856434
- Acronym / sponsor ID
- SURG-202407.01
- Conditions
- Appendicitis With Perforation, Appendectomy, Probiotic
- Keywords
- Perforated Appendicitis, Appendectomy, Probiotic, Laparotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: Lactobacillus plantarum sp ProbioticPatient with perforated appendicitis who received an intervention |
| Placebo Group | Placebo comparator | Other: Placebo GroupPatients with perforated appendicitis who did not receive an intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with diffuse peritonitis caused by appendicitis
- Patients undergoing laparotomic appendectomy.
- Patients aged 18 years or older.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus plantarum sp ProbioticOnce daily consumption | Dietary supplement | Probiotic Group |
| Placebo GroupGroup who received a placebo intervention | Other | Placebo Group |
Primary outcome
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.
3 secondary outcomes
Segmented Neutrophil level
Time frame: From the day of randomization up to 5 days postoperatively
Post operative pain level
Time frame: From the day of randomization up to 5 days postoperatively
Length of Hospital Stay
Time frame: From the day of randomization up to 5 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 36814190Guan 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.
- Individual participant dataSharing planned: Yes. All data will be available for public
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Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
Appendicitis Acute, Appendicitis Perforated
Active, not recruitingObservational study
Effect of Intraperitoneal Drain Placement on Postoperative Outcomes Following Laparoscopic Appendectomy in Adult Patients With Perforated Appendicitis
Perforated Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reno Rudiman, Professor study director
Hasan Sadikin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum sp Probiotic in people with Appendicitis With Perforation and Appendectomy, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Blood Cells Level (time frame: From the day of randomization up to 5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.