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

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Indian Journal of Gastroenterology Aims and scope Submit manuscript

Abstract

Background and Aim

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.

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.

Results

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 ± 0.27 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).

Conclusion

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.

Clinical trial registration

This study has been registered in India's clinical trial registry under the registration number CTRI/2020/02/023459).

Graphical abstract

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Acknowledgements

We are grateful to all participants in this study who had given us their valuable time and information to conduct the study. We would also like to thank our endoscopy unit staff members and non-teaching staff, who helped us in the collection of data and also in its processing.

Funding

This research did not receive any specific grant from funding agencies in public, commercial or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, Kalinga Institute of Medical Sciences, Bhubaneswar, 751 024, India

    Raj Kumar, Preetam Nath, Anil Chandra Anand, V. J. Devisetty, Anirudh Tiwari, Dibya Lochan Praharaj, Bipadabhanjan Mallick, Sarat Chandra Panigrahi & Subrat Kumar Acharya

  2. Department of Gastroenterology and Hepatology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar, 751 024, India

    Preetam Nath

  3. Department of Pathology, Kalinga Institute of Medical Sciences, Bhubaneswar, 751 024, India

    Pranati Misra

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  1. Raj Kumar
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Contributions

The authors confirm contribution to the article as follows:

RK: Conceptualization, data curation, writing original draft; PN: Project administration, manuscript writing- review, writingand editing; ACA: Conceptualization, methodology,writing- review and editing; PM, Histopathology review, manuscript review and editing; VJD: Data collection; AT: Data collection; DLP: Conceptualization, manuscript review and editing; BM: Conceptualization, manuscript review and editing; SCP: manuscript review and editing; SKA: Conceptualization, methodology and manuscript review and editing.

Corresponding author

Correspondence to Preetam Nath.

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Conflict of interest

RK, PN, ACA, PM, VJD, AT, DLP, BM, SCP and SKA declare that they have no conflict of interest.

Statement of human rights

The study has been approved by the institutional ethics committee and has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and revised in 2008.

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Yes

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The authors are solely responsible for the data and the contents of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, the Indian Society of Gastroenterology or the printer/publishers are responsible for the results/findings and content of this article.

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Kumar, R., Nath, P., Anand, A.C. et al. Combination of antimicrobials for non-specific isolated terminal ileal abnormalities - A randomized clinical trial. Indian J Gastroenterol 42, 658–667 (2023). https://doi.org/10.1007/s12664-023-01398-w

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  • DOI: https://doi.org/10.1007/s12664-023-01398-w

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