Appendicitis AcuteNCT07860307
Differences In Microbiota Profiles Of Pediatric Appendicitis Cases
A study testing Appendectomy in people with Appendicitis Acute and Disbiosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The microbial profile varies between simple appendicitis (SA) and complicated appendicitis (CA) cases. An appendectomy has been noted to temporarily diminish gut bacterial diversity. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis Acute, Disbiosis, Complicated Appendicitis
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children who were suspected of acut appendicitis (AA) based on history and physical examination.
- a confirmed diagnosis of AA, evidenced by clinical symptoms such as abdominal pain, nausea, and vomiting,
- elevated inflammatory markers (e.g., white blood cell, C-reactive protein),
- imaging findings (X-ray, ultrasounography, Computed Tomography),
- histopathological confirmation after appendectomy
Who cannot join
- prior abdominal surgery,
- other gastrointestinal diseases such as inflammatory bowel disease, and
- immunocompromised conditions including malignancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine
Istanbul, Istanbul, 34093
About this study
Official title: Differences In Microbiota Profiles Of Simple And Complicated Pediatric Appendicitis Cases
The microbial profile varies between simple appendicitis (SA) and complicated appendicitis (CA) cases. An appendectomy has been noted to temporarily diminish gut bacterial diversity. Changes in the microbial profile associated with appendicitis are known to significantly influence the development of acute appendicitis (AA). Therefore accurately distinguishing between SA and CA cases is essential for selecting suitable treatment approaches.
The aim of this clinical study is to determine whether the gut bacterial profile plays a role in cases of simple and severe appendicitis in pediatric patients. Healthy volunteers will also be included in the study for the purpose of comparing results. The key questions the researchers aim to answer are:
Are there differences in the biochemical values of participants with simple versus severe appendicitis? Are there differences in the gut bacteria present in cases of simple versus severe appendicitis? There are no specific procedures or requirements for the participants or healthy volunteers to follow. There will be no changes to their treatment or medical care.
Read the detailed description
The appendix, a 10 cm long, worm-like sac that emerges from the junction between the small and large intestines, was for years considered a persistent tissue remnant with no real function, but it was later understood to be a modest lymphatic organ that protects the intestines from pathogens. Later studies provided strong evidence that the appendix plays an additional role in harboring and supporting the normal resident microbiota, thus enabling the colon to rapidly regenerate itself after diarrhea or other bowel disorders. Acute appendicitis (AA), caused by inflammation of the appendix, is the most common reason for emergency abdominal surgery in children. AA is diagnosed in 1% to 8% of children presenting to pediatric emergency departments with acute abdominal pain. AA develops due to luminal obstruction that can occur due to fecaliths, foreign bodies, malignancy, or lymphoid hyperplasia. However, it is suggested that the pathogenesis of AA may be more closely related to dysbiosis of microbiota. The appendix microbiota can change significantly in various diseases. In AA, a decrease in microbial diversity and an increase in potentially pathogenic bacteria such as Parvimonas and Acinetobacter are observed, which may contribute to the inflammatory characteristics.
Acute appendicitis is classified into two categories: simple (uncomplicated or non-perforated) and complicated (perforated). Thus, it is essential to assess the effectiveness of various treatment approaches for these two forms of appendicitis. The mildest form of appendicitis, known as suppurative or phlegmonous appendicitis, is marked by a substantial infiltration of neutrophils into the muscular wall of the appendix. This variant is commonly termed uncomplicated or simple appendicitis (SA). In contrast, complicated appendicitis (CA) involves inflammation accompanied by vascular thrombosis, leading to necrosis of the appendix wall-gangrenous appendicitis. If the wall eventually ruptures, luminal contents leak, producing perforated appendicitis, which can precipitate a complex intra-abdominal infection. Such an infection may present as diffuse peritonitis or as a localized periapical abscess.
A healthy appendix harbors a robust and diverse community of microorganisms, such as Bacillota, Bacteriodota, Actinomycetota, and Pseudomonadota. Studies show that the gut microbiota of patients with appendicitis differs from that of healthy controls. The microbial profile also varies between SA and CA. An appendectomy has been noted to temporarily diminish gut bacterial diversity. Changes in the microbiota associated with appendicitis are known to significantly influence the pathophysiology of AA. Therefore accurately distinguishing between SA and CA cases is essential for selecting suitable treatment approaches.
This study aimed to investigate microbial differences between SA and CA in children's appendix tissue and rectal swab samples through culture and microbiota analyses, and to evaluate how these differences influence treatment decisions.
- Conditions
- Appendicitis Acute, Disbiosis, Complicated Appendicitis, Simple Appandiscitis, Microbiota Analysis in Healthy Subjects, Microbiota Composition in the Human Small Intestine
- Being tested
- Appendectomy
- Keywords
- Pre-operative treatment, Simple appendicitis, Complicated appendicitis, Microbiota analysis
- Medical subject headings
- Appendicitis, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Also called Laparoscopic appendctomy
Prophylactic antibiotic implementation
| Study group | Role | What they receive |
|---|---|---|
| Appendectomy operation | Experimental | Laparoscopic appendectomy Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendix tissues and rectal swabs were used for microbiota analysis and conventional cultures
All apendectomy operations were performed by the same clinician. Appendiceal tissue and rectal swab samples were obtained during appendectomy from patients. During operation, the diseased appendix was removed. After excising the vermiform appendix, a fragment of roughly 1 cm3 from the proximal end was cut with a sterile scalpel, placed in a sterile screw-cap container, and immediately transferred to medical microbiology laboratory. The rest of the appendix specimen was sent to pathology laboratory for routine histopathologic and microbiological examination. After this period, both aerobic / anaerobic cultures and microbiota analysis were performed.
Measured: Over a period of eight months
Results of culture and microbiota analysis
Appendix specimens collected during surgery were placed in sterile screw-capped containers and divided into two aliquots. One aliquot was stored in a deep freezer at -80ºC for subsequent microbiota analysis, while the other was immediately inoculated into thioglycolate broth and incubated at 37 °C for 48 h. After this period, both aerobic and anaerobic cultures were performed. The bacteria isolated were identified with an automated identification system and antibiotic susceptibility testing by disk diffusion method was carried out.
Only children with histopathologically confirmed appendicitis were included in final microbiota analysis. Tissue samples were prepared using Tissue Genomic DNA Extraction Kit. DNA extraction from rectal swab samples was performed utilising Stool Genomic DNA Extraction Kit. The 16S rRNA regions were amplified using a DNA preparation kit with primers designed to target the V3-V4 region.
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start18 Aug 2025
- Primary completion4 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Appendiceal tissue and rectal swab samples were obtained during appendectomy from patients. During operation, the diseased appendix was removed. After excising the vermiform appendix, a fragment of roughly 1 cm3 from the proximal end was cut with a sterile scalpel, placed in a sterile screw-cap container.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lütfiye Öksüz, Istanbul University
- Investigators
- LÜTFİYE ÖKSÜZ, PROF, Principal investigator, Istanbul UniversityLÜTFİYE ÖKSÜZ, PROF, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860307
- Sponsor's protocol ID
- 20.09.2024/18
- Other IDs
- 40812
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personal data will not be shared, as doing so would be unethical; however, data regarding the study results may be requested from the principal investigator upon request.
Publications
Jalava K, Sallinen V, Lampela H, Malmi H, Steinholt I, Augestad KM, Leppaniemi A, Mentula P. Role of Preoperative Antibiotic Treatment While Awaiting Appendectomy: The PERFECT-Antibiotics Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):745-754. doi: 10.1001/jamasurg.2025.1212.
PubMed 40366704Cao Y, Cheng Y, Pan W, Diao J, Sun L, Meng M. Gut microbiota variations in depression and anxiety: a systematic review. BMC Psychiatry. 2025 May 1;25(1):443. doi: 10.1186/s12888-025-06871-8.
PubMed 40312666Zhong D, Brower-Sinning R, Firek B, Morowitz MJ. Acute appendicitis in children is associated with an abundance of bacteria from the phylum Fusobacteria. J Pediatr Surg. 2014 Mar;49(3):441-6. doi: 10.1016/j.jpedsurg.2013.06.026.
PubMed 24650474Bi Y, Yang Q, Li J, Zhao X, Yan B, Li X, Cui H. The Gut Microbiota and Inflammatory Factors in Pediatric Appendicitis. Dis Markers. 2022 Jul 7;2022:1059445. doi: 10.1155/2022/1059445. eCollection 2022.
PubMed 35845131Guinane CM, Tadrous A, Fouhy F, Ryan CA, Dempsey EM, Murphy B, Andrews E, Cotter PD, Stanton C, Ross RP. Microbial composition of human appendices from patients following appendectomy. mBio. 2013 Jan 15;4(1):e00366-12. doi: 10.1128/mBio.00366-12.
PubMed 23322636Ma H, Wang M, Feng Y, Zhang W, Wang W, Xie Y, Kong G, Feng J, Wang P, Wang Q, Huang X. Microbial profile of the appendix niche in acute appendicitis: a novel sampling approach. FEBS Open Bio. 2025 Dec;15(12):2001-2020. doi: 10.1002/2211-5463.70105. Epub 2025 Aug 22.
PubMed 40847462Peeters T, Penders J, Smeekens SP, Galazzo G, Houben B, Netea MG, Savelkoul PH, Gyssens IC. The fecal and mucosal microbiome in acute appendicitis patients: an observational study. Future Microbiol. 2019 Jan;14:111-127. doi: 10.2217/fmb-2018-0203. Epub 2019 Jan 21.
PubMed 30663346Jackson HT, Mongodin EF, Davenport KP, Fraser CM, Sandler AD, Zeichner SL. Culture-independent evaluation of the appendix and rectum microbiomes in children with and without appendicitis. PLoS One. 2014 Apr 23;9(4):e95414. doi: 10.1371/journal.pone.0095414. eCollection 2014.
PubMed 24759879Vanhatalo S, Munukka E, Kallonen T, Sippola S, Gronroos J, Haijanen J, Hakanen AJ, Salminen P. Appendiceal microbiome in uncomplicated and complicated acute appendicitis: A prospective cohort study. PLoS One. 2022 Oct 14;17(10):e0276007. doi: 10.1371/journal.pone.0276007. eCollection 2022.
PubMed 36240181Salo M, Marungruang N, Roth B, Sundberg T, Stenstrom P, Arnbjornsson E, Fak F, Ohlsson B. Evaluation of the microbiome in children's appendicitis. Int J Colorectal Dis. 2017 Jan;32(1):19-28. doi: 10.1007/s00384-016-2639-x. Epub 2016 Sep 9.
PubMed 27613729Aiyoshi T, Kakihara T, Watanabe E, Tanaka N, Ogata Y, Masuoka H, Kurokawa R, Fujishiro J, Masumoto K, Suda W. A comprehensive microbial analysis of pediatric patients with acute appendicitis. J Microbiol Immunol Infect. 2023 Aug;56(4):695-704. doi: 10.1016/j.jmii.2023.03.006. Epub 2023 Mar 21.
PubMed 37029071Oh SJ, Pimentel M, Leite GGS, Celly S, Villanueva-Millan MJ, Lacsina I, Chuang B, Parodi G, Morales W, Weitsman S, Singer-Englar T, Barlow GM, Zhai J, Pichestshote N, Rezaie A, Mathur R, Pimentel M. Acute appendicitis is associated with appendiceal microbiome changes including elevated Campylobacter jejuni levels. BMJ Open Gastroenterol. 2020 Jun;7(1):e000412. doi: 10.1136/bmjgast-2020-000412.
PubMed 32499276Hickman-Davis JM, O'Reilly P, Davis IC, Peti-Peterdi J, Davis G, Young KR, Devlin RB, Matalon S. Killing of Klebsiella pneumoniae by human alveolar macrophages. Am J Physiol Lung Cell Mol Physiol. 2002 May;282(5):L944-56. doi: 10.1152/ajplung.00216.2001.
PubMed 11943658Hattori T, Yuasa N, Ikegami S, Nishiyama H, Takeuchi E, Miyake H, Kuno R, Miyata K, Fujino M, Minami M. Culture-based bacterial evaluation of the appendix lumen in patients with and without acute appendicitis. J Infect Chemother. 2019 Sep;25(9):708-713. doi: 10.1016/j.jiac.2019.03.021. Epub 2019 Apr 11.
PubMed 30982727Song DW, Park BK, Suh SW, Lee SE, Kim JW, Park JM, Kim HR, Lee MK, Choi YS, Kim BG, Park YG. Bacterial culture and antibiotic susceptibility in patients with acute appendicitis. Int J Colorectal Dis. 2018 Apr;33(4):441-447. doi: 10.1007/s00384-018-2992-z. Epub 2018 Feb 27.
PubMed 29488087
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences In Microbiota Profiles Of Simple And Complicated Pediatric Appendicitis Cases
- ClinicalTrials.gov ID
- NCT07860307
- Acronym / sponsor ID
- 20.09.2024/18
- Conditions
- Appendicitis Acute, Disbiosis, Complicated Appendicitis, Simple Appandiscitis, Microbiota Analysis in Healthy Subjects, Microbiota Composition in the Human Small Intestine
- Keywords
- Pre-operative treatment, Simple appendicitis, Complicated appendicitis, Microbiota analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 6 Oct 2026 (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.
The microbial profile varies between simple appendicitis (SA) and complicated appendicitis (CA) cases. An appendectomy has been noted to temporarily diminish gut bacterial diversity. Changes in the microbial profile associated with appendicitis are known to significantly influence the development of acute appendicitis (AA). Therefore accurately distinguishing between SA and CA cases is essential for selecting suitable treatment approaches.
The aim of this clinical study is to determine whether the gut bacterial profile plays a role in cases of simple and severe appendicitis in pediatric patients. Healthy volunteers will also be included in the study for the purpose of comparing results. The key questions the researchers aim to answer are:
Are there differences in the biochemical values of participants with simple versus severe appendicitis? Are there differences in the gut bacteria present in cases of simple versus severe appendicitis? There are no specific procedures or requirements for the participants or healthy volunteers to follow. There will be no changes to their treatment or medical care.
Detailed description
The appendix, a 10 cm long, worm-like sac that emerges from the junction between the small and large intestines, was for years considered a persistent tissue remnant with no real function, but it was later understood to be a modest lymphatic organ that protects the intestines from pathogens. Later studies provided strong evidence that the appendix plays an additional role in harboring and supporting the normal resident microbiota, thus enabling the colon to rapidly regenerate itself after diarrhea or other bowel disorders. Acute appendicitis (AA), caused by inflammation of the appendix, is the most common reason for emergency abdominal surgery in children. AA is diagnosed in 1% to 8% of children presenting to pediatric emergency departments with acute abdominal pain. AA develops due to luminal obstruction that can occur due to fecaliths, foreign bodies, malignancy, or lymphoid hyperplasia. However, it is suggested that the pathogenesis of AA may be more closely related to dysbiosis of microbiota. The appendix microbiota can change significantly in various diseases. In AA, a decrease in microbial diversity and an increase in potentially pathogenic bacteria such as Parvimonas and Acinetobacter are observed, which may contribute to the inflammatory characteristics.
Acute appendicitis is classified into two categories: simple (uncomplicated or non-perforated) and complicated (perforated). Thus, it is essential to assess the effectiveness of various treatment approaches for these two forms of appendicitis. The mildest form of appendicitis, known as suppurative or phlegmonous appendicitis, is marked by a substantial infiltration of neutrophils into the muscular wall of the appendix. This variant is commonly termed uncomplicated or simple appendicitis (SA). In contrast, complicated appendicitis (CA) involves inflammation accompanied by vascular thrombosis, leading to necrosis of the appendix wall-gangrenous appendicitis. If the wall eventually ruptures, luminal contents leak, producing perforated appendicitis, which can precipitate a complex intra-abdominal infection. Such an infection may present as diffuse peritonitis or as a localized periapical abscess.
A healthy appendix harbors a robust and diverse community of microorganisms, such as Bacillota, Bacteriodota, Actinomycetota, and Pseudomonadota. Studies show that the gut microbiota of patients with appendicitis differs from that of healthy controls. The microbial profile also varies between SA and CA. An appendectomy has been noted to temporarily diminish gut bacterial diversity. Changes in the microbiota associated with appendicitis are known to significantly influence the pathophysiology of AA. Therefore accurately distinguishing between SA and CA cases is essential for selecting suitable treatment approaches.
This study aimed to investigate microbial differences between SA and CA in children's appendix tissue and rectal swab samples through culture and microbiota analyses, and to evaluate how these differences influence treatment decisions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Appendiceal tissue and rectal swab samples were obtained during appendectomy from patients. During operation, the diseased appendix was removed. After excising the vermiform appendix, a fragment of roughly 1 cm3 from the proximal end was cut with a sterile scalpel, placed in a sterile screw-cap container.
| Arm | Type | Receives |
|---|---|---|
| Appendectomy operation | Experimental | Procedure: AppendectomyLaparoscopic appendectomy |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children who were suspected of acut appendicitis (AA) based on history and physical examination.
- a confirmed diagnosis of AA, evidenced by clinical symptoms such as abdominal pain, nausea, and vomiting,
- elevated inflammatory markers (e.g., white blood cell, C-reactive protein),
- imaging findings (X-ray, ultrasounography, Computed Tomography),
- histopathological confirmation after appendectomy
Key exclusion criteria (3 listed)
- prior abdominal surgery,
- other gastrointestinal diseases such as inflammatory bowel disease, and
- immunocompromised conditions including malignancy.
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 |
|---|---|---|
| AppendectomyAlso: Laparoscopic appendctomyProphylactic antibiotic implementation | Procedure or surgery | Appendectomy operation |
Primary outcome
Appendix tissues and rectal swabs were used for microbiota analysis and conventional cultures
Time frame: Over a period of eight months
All apendectomy operations were performed by the same clinician. Appendiceal tissue and rectal swab samples were obtained during appendectomy from patients. During operation, the diseased appendix was removed. After excising the vermiform appendix, a fragment of roughly 1 cm3 from the proximal end was cut with a sterile scalpel, placed in a sterile screw-cap container, and immediately transferred to medical microbiology laboratory. The rest of the appendix specimen was sent to pathology laboratory for routine histopathologic and microbiological examination. After this period, both aerobic / anaerobic cultures and microbiota analysis were performed.
Results of culture and microbiota analysis
Time frame: eight months
Appendix specimens collected during surgery were placed in sterile screw-capped containers and divided into two aliquots. One aliquot was stored in a deep freezer at -80ºC for subsequent microbiota analysis, while the other was immediately inoculated into thioglycolate broth and incubated at 37 °C for 48 h. After this period, both aerobic and anaerobic cultures were performed. The bacteria isolated were identified with an automated identification system and antibiotic susceptibility testing by disk diffusion method was carried out. Only children with histopathologically confirmed appendicitis were included in final microbiota analysis. Tissue samples were prepared using Tissue Genomic DNA Extraction Kit. DNA extraction from rectal swab samples was performed utilising Stool Genomic DNA Extraction Kit. The 16S rRNA regions were amplified using a DNA preparation kit with primers designed to target the V3-V4 region.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 40366704Jalava K, Sallinen V, Lampela H, Malmi H, Steinholt I, Augestad KM, Leppaniemi A, Mentula P. Role of Preoperative Antibiotic Treatment While Awaiting Appendectomy: The PERFECT-Antibiotics Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):745-754. doi: 10.1001/jamasurg.2025.1212.
- Background: PubMed 40312666Cao Y, Cheng Y, Pan W, Diao J, Sun L, Meng M. Gut microbiota variations in depression and anxiety: a systematic review. BMC Psychiatry. 2025 May 1;25(1):443. doi: 10.1186/s12888-025-06871-8.
- Background: PubMed 24650474Zhong D, Brower-Sinning R, Firek B, Morowitz MJ. Acute appendicitis in children is associated with an abundance of bacteria from the phylum Fusobacteria. J Pediatr Surg. 2014 Mar;49(3):441-6. doi: 10.1016/j.jpedsurg.2013.06.026.
- Background: PubMed 35845131Bi Y, Yang Q, Li J, Zhao X, Yan B, Li X, Cui H. The Gut Microbiota and Inflammatory Factors in Pediatric Appendicitis. Dis Markers. 2022 Jul 7;2022:1059445. doi: 10.1155/2022/1059445. eCollection 2022.
- Background: PubMed 23322636Guinane CM, Tadrous A, Fouhy F, Ryan CA, Dempsey EM, Murphy B, Andrews E, Cotter PD, Stanton C, Ross RP. Microbial composition of human appendices from patients following appendectomy. mBio. 2013 Jan 15;4(1):e00366-12. doi: 10.1128/mBio.00366-12.
- Background: PubMed 40847462Ma H, Wang M, Feng Y, Zhang W, Wang W, Xie Y, Kong G, Feng J, Wang P, Wang Q, Huang X. Microbial profile of the appendix niche in acute appendicitis: a novel sampling approach. FEBS Open Bio. 2025 Dec;15(12):2001-2020. doi: 10.1002/2211-5463.70105. Epub 2025 Aug 22.
- Background: PubMed 30663346Peeters T, Penders J, Smeekens SP, Galazzo G, Houben B, Netea MG, Savelkoul PH, Gyssens IC. The fecal and mucosal microbiome in acute appendicitis patients: an observational study. Future Microbiol. 2019 Jan;14:111-127. doi: 10.2217/fmb-2018-0203. Epub 2019 Jan 21.
- Background: PubMed 24759879Jackson HT, Mongodin EF, Davenport KP, Fraser CM, Sandler AD, Zeichner SL. Culture-independent evaluation of the appendix and rectum microbiomes in children with and without appendicitis. PLoS One. 2014 Apr 23;9(4):e95414. doi: 10.1371/journal.pone.0095414. eCollection 2014.
- Background: PubMed 36240181Vanhatalo S, Munukka E, Kallonen T, Sippola S, Gronroos J, Haijanen J, Hakanen AJ, Salminen P. Appendiceal microbiome in uncomplicated and complicated acute appendicitis: A prospective cohort study. PLoS One. 2022 Oct 14;17(10):e0276007. doi: 10.1371/journal.pone.0276007. eCollection 2022.
- Background: PubMed 27613729Salo M, Marungruang N, Roth B, Sundberg T, Stenstrom P, Arnbjornsson E, Fak F, Ohlsson B. Evaluation of the microbiome in children's appendicitis. Int J Colorectal Dis. 2017 Jan;32(1):19-28. doi: 10.1007/s00384-016-2639-x. Epub 2016 Sep 9.
- Background: PubMed 37029071Aiyoshi T, Kakihara T, Watanabe E, Tanaka N, Ogata Y, Masuoka H, Kurokawa R, Fujishiro J, Masumoto K, Suda W. A comprehensive microbial analysis of pediatric patients with acute appendicitis. J Microbiol Immunol Infect. 2023 Aug;56(4):695-704. doi: 10.1016/j.jmii.2023.03.006. Epub 2023 Mar 21.
- Background: PubMed 32499276Oh SJ, Pimentel M, Leite GGS, Celly S, Villanueva-Millan MJ, Lacsina I, Chuang B, Parodi G, Morales W, Weitsman S, Singer-Englar T, Barlow GM, Zhai J, Pichestshote N, Rezaie A, Mathur R, Pimentel M. Acute appendicitis is associated with appendiceal microbiome changes including elevated Campylobacter jejuni levels. BMJ Open Gastroenterol. 2020 Jun;7(1):e000412. doi: 10.1136/bmjgast-2020-000412.
- Istanbul University Scientific Research Projects Coordination UnitLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Personal data will not be shared, as doing so would be unethical; however, data regarding the study results may be requested from the principal investigator upon request.
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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.
LÜTFİYE ÖKSÜZ, PROF principal investigator
Istanbul University
LÜTFİYE ÖKSÜZ, PROF study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appendectomy in people with Appendicitis Acute and Disbiosis, run by Istanbul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 6 Oct 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Appendix tissues and rectal swabs were used for microbiota analysis and conventional cultures (time frame: Over a period of eight months). The study lists 2 primary outcomes in all. 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 NCT07860307, which also lists 26 linked publications.
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 6 Oct 2026.