The effects of probiotic treatment with Bifidobacterium breve, Bif195 for small intestinal Crohn's disease and the gut microbiome: results from a randomised, double-blind, placebo-controlled trial.

IF 4.3 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gut Pathogens Pub Date : 2025-04-09 DOI:10.1186/s13099-025-00692-6

Ida Marie Bruun Grønbæk, Sofie Ingdam Halkjær, Sarah Mollerup, Esben Holm Hansen, Sarah Juel Paulsen, Sara Engel, Klaus Theede, Rune Wilkens, Trine Boysen, Andreas Munk Petersen

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Abstract

Background: The aetiology of Crohn's disease, a chronic inflammatory bowel disease, is multifactorial and not completely understood. However, the association with gut dysbiosis is well-established, and manipulation of the gut microbiota has gained interest as a treatment strategy. This study aimed to investigate the effects of the probiotic strain Bifidobacterium breve, Bif195™ (Bif195) on intestinal inflammation, symptoms, and the gut microbiome composition in patients with small intestinal Crohn's disease.

Methods: This was a randomised, double-blind, placebo-controlled trial. Thirty-three patients with small intestinal Crohn's disease were assigned to eight weeks of treatment with Bif195 or placebo (1:1). The primary outcome was changes in bowel wall thickness measured by intestinal ultrasonography. Other outcomes were changes in symptom severity, quality of life, faecal calprotectin, fatigue, and specific inflammatory parameters on ultrasonography. Changes in the microbiome composition were also examined.

Results: Bif195 did not affect the bowel wall thickness in the small intestine compared to placebo. Nor did we observe effects on secondary or clinical explorative outcomes. Analysis of the gut microbiome showed that the relative abundance of B. breve rose during the intervention in the Bif195 group, but the result was statistically non-significant. Surprisingly, we observed a clustering of baseline microbiome data into two groups that differed in several aspects including a statistically significant difference in the incidence of previous bowel resections among the participants. Furthermore, changes in symptom scores after eight weeks of intervention were significantly different across the two microbiome groups, with an interaction effect of p = 0.04.

Conclusions: Eight weeks of treatment with Bif195 did not affect clinical outcomes for Crohn's disease. However, variations in baseline microbiome data influenced the results. This underscores the importance of assessing baseline microbiome data in intervention studies in Crohn's disease.

Clinicaltrials: gov NCT04842149.

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短双歧杆菌、Bif195治疗小肠克罗恩病和肠道微生物组的效果：一项随机、双盲、安慰剂对照试验的结果

背景：克罗恩病是一种慢性炎症性肠病，其病因是多因素的，尚不完全清楚。然而，与肠道生态失调的关联是公认的，并且肠道微生物群的操纵作为一种治疗策略已经引起了人们的兴趣。本研究旨在探讨益生菌菌株短双歧杆菌Bif195™（Bif195）对小肠克罗恩病患者肠道炎症、症状和肠道微生物组成的影响。方法：这是一项随机、双盲、安慰剂对照试验。33名患有小肠克罗恩病的患者被分配使用Bif195或安慰剂（1:1）进行8周的治疗。主要观察指标为肠超声检查测得的肠壁厚度变化。其他结果包括症状严重程度、生活质量、粪便钙保护蛋白、疲劳和超声检查特异性炎症参数的变化。微生物组组成的变化也被检查。结果：与安慰剂相比，Bif195对小肠肠壁厚度没有影响。我们也没有观察到对继发性或临床探索性结果的影响。肠道微生物组分析显示，在bi195组干预期间，短梭菌的相对丰度有所上升，但结果无统计学意义。令人惊讶的是，我们观察到基线微生物组数据聚类成两组，这两组在几个方面存在差异，包括参与者中既往肠道切除术发生率的统计学显著差异。此外，干预8周后症状评分的变化在两个微生物组之间有显著差异，p = 0.04的交互效应。结论：用Bif195治疗8周对克罗恩病的临床结果没有影响。然而，基线微生物组数据的变化影响了结果。这强调了在克罗恩病干预研究中评估基线微生物组数据的重要性。临床试验：gov NCT04842149。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gut Pathogens GASTROENTEROLOGY & HEPATOLOGY-MICROBIOLOGY

CiteScore

7.70

自引率

2.40%

发文量

期刊介绍： Gut Pathogens is a fast publishing, inclusive and prominent international journal which recognizes the need for a publishing platform uniquely tailored to reflect the full breadth of research in the biology and medicine of pathogens, commensals and functional microbiota of the gut. The journal publishes basic, clinical and cutting-edge research on all aspects of the above mentioned organisms including probiotic bacteria and yeasts and their products. The scope also covers the related ecology, molecular genetics, physiology and epidemiology of these microbes. The journal actively invites timely reports on the novel aspects of genomics, metagenomics, microbiota profiling and systems biology. Gut Pathogens will also consider, at the discretion of the editors, descriptive studies identifying a new genome sequence of a gut microbe or a series of related microbes (such as those obtained from new hosts, niches, settings, outbreaks and epidemics) and those obtained from single or multiple hosts at one or different time points (chronological evolution).