Combination of antimicrobials for non-specific isolated terminal ileal abnormalities - A randomized clinical trial.

Abstract

Non-specific isolated terminal ileum abnormalities (NSITIA) namely erosions, ulcer and nodularity are frequent findings on ileal examination during colonoscopy. Their clinical significance and management are uncertain. A pilot randomized clinical trial comparing combination antimicrobial therapy (oralRifaximin 550mg twice daily for twoweeks; Albendazole 400mg orally as a single dose; Tinidazole 1 gm twice daily for threedays i.e. Group A) with symptomatic treatment (Group B) was performed in patients with NSITIA, which was diagnosed on the basis of colonoscopy and histopathology features. The primary outcome measure was mucosal healing on follow-up ileocolonoscopy at three months of randomization. Additionally, clinical, endoscopic and histological findings were noted at baseline and after a follow-up of threemonths. Total 60 patients with NSITIA were randomized. The most prevalent symptoms were abdominal discomfort (n = 37, 61.6%), diarrhea (n = 25, 41.6%) and constipation (n = 24, 40%). The incidence of ulcers, nodularity and erosions were (n = 18, 62.1%), (n = 8, 27.6%) and (n = 3, 10.34%) in group A and (n = 18, 58%), (n = 9, 29%), (n = 4, 13%) in group B, respectively. After a mean follow-up duration of 3.36 ± 0.27months, both groups showed comparable resolution in clinical symptoms (n = 24, 92.4% vs. n = 24, 88.8%, p = 0.954), ileocolonoscopic findings (n = 23, 88.5% vs. n = 22, 81.5%, p = 0.765) and histological characteristics (n = 20, 76.5% vs. n = 19, 70.4%, p = 0.806). The clinical, endoscopic and histopathological remission occurs in most patients with NSITIA. The use of antimicrobials including antibiotic, antiprotozoal and anthelminthic therapy did not have any impact on the rate of mucosal healing in these patients. Our study is a pilot study and has some limitations such as small sample size and lack of complete small bowel workup in all patients, which leaves a possibility of undetected ulcers proximal to the terminal ileum. This study has been registered in India's clinical trial registry under the registration number CTRI/2020/02/023459 ).