An interventional study of Appendectomy in Appendicitis Acute, Disbiosis and Complicated Appendicitis, sponsored by Istanbul University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Istanbul University · Not applicable, Interventional, and Basic science
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.
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.
412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.
This study's enrollment of 50 is below the median of 111 across 246 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic appendectomy
Procedure: Appendectomy
Prophylactic antibiotic implementation
Also known as: Laparoscopic appendctomy
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.
Time frame: 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.
Time frame: eight months
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr, Analytic code
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul University