Bif195 probiotic RCT in IBS-D patients, Copenhagen, Denmark

Background: Patients with irritable bowel syndrome experience abdominal pain and stool habit disturbances, and often also extraintestinal symptoms such as fatigue. The disorder is linked to gut dysbiosis, and manipulation of the microbiota is considered a possible focus of treatment strategies.</p><p>Aim: We aim to investigate the effect of the probiotic strain Bifidobacterium breve, Bif195 (DSM 33360) (Bif195) on symptoms and gut microbiome composition in patients with diarrhoea-predominant irritable bowel syndrome.</p><p>Methods: This was a randomised, double-blind, placebo-controlled study. Sixty-one patients with moderate to severe disease activity were allocated to eight weeks of treatment with either Bif195 or placebo (1:1) followed by eight weeks of follow-up. The primary outcome was improvement of symptoms measured by the validated questionnaire IBS-symptom severity scale. Secondary and explorative outcomes were the effects of Bif195 on intestinal symptoms, quality of life, fatigue, and the gut microbiota. Modulation of transepithelial electrical resistance (TEER) of Caco-2 cells by Bif195 was investigated in vitro as a model of barrier integrity.</p><p>Results: Bif195 did not affect primary or secondary outcomes however, we found that Bif195 lowered fatigue scores compared to placebo. The relative abundance of Bifidobacterium breve was increased in the Bif195 group after eight weeks of treatment and returned to baseline after eight weeks of follow-up. Bif195 significantly increased TEER readings in vitro indicating enhanced barrier integrity.</p><p>Conclusions: Eight weeks of treatment with probiotic Bif195 did not change intestinal symptoms, but lowered fatigue scores compared to placebo and enhanced barrier integrity in vitro.</p><p>Clinicaltrials.gov: NCT04808271

Classified as human gut / stool shotgun DNA metagenome of adult by sonnet_x2 with confidence 0.70. Assay shotgun_dna.

• host run.host_tax_id · “9606”
• body site run.scientific_name · “human gut metagenome”
• life stage study.description · “Sixty-one patients with moderate to severe disease”

258 runs over 258 samples · mean 0.64 Gbp per run (median 0.60 Gbp, total 166.13 Gbp; 258 runs with a base count) · layout PAIRED 258 · platform ILLUMINA 258 · models NextSeq 500 (258) · 99% of runs with a Sandpiper profile · first public 2025-05-29 – 2025-06-01

Grønbæk IMB first · Halkjær SI · Hansen EH · Mollerup S · Paulsen SJ · Konrad CV · Engel S · Bulinska-Balas M · Wellejus A · Haaber AB · Christensen AH · Engsbro AL · Petersen AM last

PRJNA1269031.csv.gz (9.0 KB) · parquet (83.0 KB) — all 258 samples, every field with route and confidence · PRJNA1269031_determinations.csv.gz (28.0 KB) — 3,663 evidence rows