Trial reportIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2023
Combination of antimicrobials for non-specific isolated terminal ileal abnormalities - A randomized clinical trial.
Trial report in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors at 1 institution in 1 country.
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Abstract
BACKGROUND AND
aimNon-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. METHODOLOGY: A pilot randomized clinical trial comparing combination antimicrobial therapy (oral Rifaximin 550 mg twice daily for two weeks; Albendazole 400 mg orally as a single dose; Tinidazole 1 gm twice daily for three days 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 three months.
resultsTotal 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 ± 0.27 months, 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).
conclusionThe 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. CLINICAL
trial registrationThis study has been registered in India's clinical trial registry under the registration number CTRI/2020/02/023459 ).
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