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

Raqib R, Sarker P, Mily A, Alam NH, Arifuzzaman AS, Rekha RS, Andersson J, Gudmundsson GH, Cravioto A, Agerberth B

BMC infectious diseases10 May 2012Cited by 73 (Europe PMC)

PMID22574737PMCIDPMC3447723DOI10.1186/1471-2334-12-111PepBankPUB-22574737

Summary

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.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

No result from this study comes from a test of the peptide.

Natural levels measured2

These results measure the body's own peptide. Nobody was given the peptide. They are not evidence about taking it. They are left out of key results, evidence counts and charts.

01HumanEndogenous levelRandomized controlled trialEfficacy outcome
In adults with shigellosis, stool concentration of LL‑37 remained significantly higher in the butyrate group than in the placebo group on days 4 and 7.
In plain wordsIn adults with shigellosis, the body's own LL‑37 in stool stayed higher with butyrate enemas than with placebo on days four and seven.
Peptide
LL-37
Outcome
IncreaseStool LL-37 concentration on days 4 and 7
Study
n = 80
Comparator
Placebo (normal saline)
Analysis
Secondary
Outcome group
Immune response · Gastrointestinal
Source sentences
Summary
Stool concentration of LL-37 remained significantly higher in the Intervention group on days 4 and 7.
2 context sentences(design, population, supporting numbers)
Summary · context
Eighty adult patients with shigellosis were randomized to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40).
Summary · context
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.
This result measures the body's own LL-37. Nobody was given the peptide. It is not evidence about taking it.
Show in the study text Report a problemFND-2257473702
02HumanEndogenous levelRandomized controlled trialEfficacy outcome
In adults with shigellosis, butyrate enema induced LL‑37 expression in the rectal epithelia.
In plain wordsIn adults with shigellosis, a butyrate enema raised the body's own LL‑37 in the rectal lining.
Peptide
LL-37
Outcome
IncreaseLL-37 expression in rectal epithelia (immunostaining)
Study
n: not reported in source
Comparator
Placebo (normal saline)
Analysis
Secondary
Outcome group
Immune response · Gastrointestinal
Source sentences
Summary
Butyrate treatment induced LL-37 expression in the rectal epithelia.
2 context sentences(design, population, supporting numbers)
Summary · context
Eighty adult patients with shigellosis were randomized to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40).
Summary · context
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.
This result measures the body's own LL-37. Nobody was given the peptide. It is not evidence about taking it.
Show in the study text Report a problemFND-2257473701

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT00800930

Therapeutic Induction of Endogenous Antibiotics

International Centre for Diarrhoeal Disease Research, Bangladeshn = 80Jan 2005 to Jan 2009

Shigellosis

Trial page ClinicalTrials.govUpdated 8 Dec 2011

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 2
9 Oct 2026, 03:03 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 02:58 UTC
First added · source update from Europe PMC

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