Evidence map›Paper›PMID 22574737›Full record

Trial reportBMC infectious diseases2012

Efficacy of sodium butyrate adjunct therapy in shigellosis: a randomized, double-blind, placebo-controlled clinical trial.

Rubhana Raqib, Protim Sarker, Akhirunnesa Mily, Nur Haque Alam, Abu Saleh Mohammed Arifuzzaman, Rokeya Sultana Rekha, Jan Andersson, Gudmundur H Gudmundsson, Alejandro Cravioto, Birgitta Agerberth

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00800930 (Therapeutic Induction of Endogenous Antibiotics for Improved Recovery in Shigellosis), which is not on this map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00800930 phase2completednot on this map

Therapeutic Induction of Endogenous Antibiotics for Improved Recovery in Shigellosis

TypeinterventionalSponsorInternational Centre for Diarrhoeal Disease Research, BangladeshRan2005 to 2009Enrolled80ConditionsShigellosisArmsSodium Butyrate, Saline
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 91 citations in OpenAlex.

  1. Trial
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  3. Shigellosis.Lancet (London, England) · 2025
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  10. Repurposing HDAC inhibitors to enhance ribonuclease 4 and 7 expression and reduce urinary tract infection.Proceedings of the National Academy of Sciences of the United States of America · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 3 countries.

Rubhana RaqibInternational Centre for Diarrheal Disease Research, Dhaka, Bangladesh. rubhana@icddrb.org
Protim Sarker
Akhirunnesa Mily
Nur Haque Alam
Abu Saleh Mohammed Arifuzzaman
Rokeya Sultana Rekha
Jan Andersson
Gudmundur H Gudmundsson
Alejandro Cravioto
Birgitta Agerberth
International Centre for Diarrhoeal Disease Research · BDKarolinska Institutet · SEKarolinska University Hospital · SEUniversity of Iceland · IS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment of shigellosis in rabbits with butyrate reduces clinical severity and counteracts the downregulation of cathelicidin (CAP-18) in the large intestinal epithelia. Here, we aimed to evaluate whether butyrate can be used as an adjunct to antibiotics in the treatment of shigellosis in patients.

methodsA randomized, double-blind, placebo-controlled, parallel-group designed clinical trial was conducted. Eighty adult patients with shigellosis were randomized to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40). The Intervention group was given an enema containing sodium butyrate (80 mM), twice daily for 3 days, while the Placebo group received the same dose of normal saline. The primary endpoint of the trial was to assess the efficacy of butyrate in improving clinical, endoscopic and histological features of shigellosis. The secondary endpoint was to study the effect of butyrate on the induction of antimicrobial peptides in the rectum. Clinical outcomes were assessed and concentrations of antimicrobial peptides (LL-37, human beta defensin1 [HBD-1] and human beta defensin 3 [HBD-3]) and pro-inflammatory cytokines (interleukin-1β [IL-1β] and interleukin-8 [IL-8]) were measured in the stool. Sigmoidoscopic and histopathological analyses, and immunostaining of LL-37 in the rectal mucosa were performed in a subgroup of patients.

resultsCompared with placebo, butyrate therapy led to the early reduction of macrophages, pus cells, IL-8 and IL-1β in the stool and improvement in rectal histopathology. Butyrate treatment induced LL-37 expression in the rectal epithelia. Stool concentration of LL-37 remained significantly higher in the Intervention group on days 4 and 7.

conclusionAdjunct therapy with butyrate during shigellosis led to early reduction of inflammation and enhanced LL-37 expression in the rectal epithelia with prolonged release of LL-37 in the stool.

trial registrationClinicalTrials.gov, NCT00800930.

Indexed as

AdolescentAdultAnimalsAnti-Bacterial AgentsAnti-Inflammatory AgentsButyratesClinical MedicineDouble-Blind MethodDrug Therapy, CombinationDysentery, BacillaryEndoscopyFecesFemaleHistocytochemistryHumansMaleAnti-Bacterial AgentsAnti-Inflammatory AgentsButyratesPlacebos

Identifiers

PMID22574737
PMCPMC3447723
OpenAlexW2039062534

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.