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Study · Non-randomized trial · n = 10 · 2026

2 results

Investigation of the stool microbiome of short bowel syndrome patients before and after a 24-week treatment with the glucagon-like peptide 2 analog glepaglutide.

Pinar I, Nielsen TSS, Brach T, Moll JM, Nielsen BH, Hvistendahl MK, Berner-Hansen M, Jeppesen PB

Clinical nutrition ESPEN25 Feb 2026

PMID41759957 (opens in a new tab)DOI10.1016/j.clnesp.2026.102989 (opens in a new tab)PepBankPUB-41759957
Publisher pagePubMedAsk about this study
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Summary

Background and aimsGlepaglutide is a long-acting glucagon-like peptide 2 (GLP-2) analog under development for the treatment of short bowel syndrome (SBS). Glepaglutide enhances intestinal absorption, which may hypothetically lead to changes in the intestinal microbiota, mainly by slowing gastrointestinal transit time. This study evaluated whether glepaglutide affects bacterial load and composition of the intestinal microbiota in SBS patients enrolled in a phase 3b trial assessing its 24-week efficacy on intestinal wet weight and energy absorption.MethodsIn this single-center, open-label, EASE SBS-4 phase 3b study, 10 patients with SBS (8 of the 10 with intestinal failure and 8 of the 10 without colon-in-continuity) were treated with glepaglutide 10 mg by subcutaneous injection once weekly for 24 weeks. While the primary trial findings demonstrated increased intestinal wet weight and energy absorption assessed by metabolic balance studies, this study investigated whether these adaptations were associated with changes in bacterial load and composition of the intestinal microbiota. Samples were obtained from either stool or ostomy effluent at baseline and after 24 weeks of treatment with glepaglutide. Bacterial load was quantified using a spike-in approach, and microbiota composition was assessed by V3V4 16S rRNA gene sequencing.ResultsNo major changes in bacterial load or microbiota composition were observed following glepaglutide treatment. Bacterial load showed distinct differences between patients with and without a colon-in-continuity; in patients without a colon, most samples had values below 109 cells per gram, whereas those with a colon-in-continuity had bacterial loads within the physiological range observed in healthy individuals, ranging from 1010 to 1011 cells per gram feces. Microbiota composition also differed markedly by intestinal anatomy: patients without a colon-in-continuity had higher abundances of genera mainly associated with the upper gastrointestinal tract, such as Streptococcus, while those with a colon-in-continuity exhibited greater abundance of genera more commonly found in the lower gastrointestinal tract, including Bifidobacterium.ConclusionsTreatment with the GLP-2 analog glepaglutide increased intestinal wet weight and energy absorption without altering the intestinal bacterial microbiota in the majority of the SBS patients participating in this study. Differences in bacterial load and composition were influenced by intestinal anatomy.Clinicaltrialsgov no: NCT04991311; ClincalTrialsRegister.eu EudraCT no: 2020-005194-27.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In patients with short bowel syndrome, glepaglutide produced no major changes in intestinal bacterial load after treatment.

    In plain wordsIn patients with short bowel syndrome, intestinal bacterial amounts showed no major changes after glepaglutide treatment.

    Peptide
    Glepaglutide
    Outcome
    No significant changeIntestinal bacterial load
    Study

    n = 10

    Outcome group
    Gut microbiota · Gastrointestinal
    Studied dose
    10 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    No major changes in bacterial load or microbiota composition were observed following glepaglutide treatment.
    1 context sentence
    Summary · context
    In this single-center, open-label, EASE SBS-4 phase 3b study, 10 patients with SBS (8 of the 10 with intestinal failure and 8 of the 10 without colon-in-continuity) were treated with glepaglutide 10 mg by subcutaneous injection once weekly for 24 weeks.
  2. 02HumanNon-randomized trialEfficacy outcome

    In patients with short bowel syndrome, glepaglutide produced no major changes in intestinal microbiota composition after treatment.

    In plain wordsIn patients with short bowel syndrome, the mix of intestinal bacteria showed no major changes after glepaglutide treatment.

    Peptide
    Glepaglutide
    Outcome
    No significant changeIntestinal microbiota composition
    Study

    n = 10

    Outcome group
    Gut microbiota · Gastrointestinal
    Studied dose
    10 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    No major changes in bacterial load or microbiota composition were observed following glepaglutide treatment.
    1 context sentence
    Summary · context
    In this single-center, open-label, EASE SBS-4 phase 3b study, 10 patients with SBS (8 of the 10 with intestinal failure and 8 of the 10 without colon-in-continuity) were treated with glepaglutide 10 mg by subcutaneous injection once weekly for 24 weeks.

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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.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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