Effectiveness of a Balanced Nine-Strain Synbiotic in Primary-Care Irritable Bowel Syndrome Patients-A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial.
Nutrients
; 16(10)2024 May 16.
Article
em En
| MEDLINE
| ID: mdl-38794741
ABSTRACT
The aim of the study was to characterize effects of a multi-strain synbiotic in patients with moderate to severe irritable bowel syndrome (IBS) of all stool form types. A total of 202 adult IBS patients were randomized (11) and after a four-week treatment-free run-in phase and were treated either with the synbiotic or a placebo for 12 weeks. The primary endpoints were the assessment of the severity of IBS symptoms (IBS-SSS) and the improvement of IBS global symptoms (IBS-GIS). Secondary endpoints comprised adequate relief (IBS-AR scale), stool form type (Bristol Stool Form Scale), bowel movements, severity of abdominal pain and bloating, stool pressure, feeling of incomplete stool evacuation, and adverse events. A total of 201 patients completed the study. Synbiotic treatment, in comparison to placebo, significantly improved IBS-SSS and IBS-GIS scores. At the end of the treatment, 70% of patients in the synbiotic group achieved adequate relief. After 12 weeks of treatment, the secondary endpoints were favorably differentiated in the synbiotic group when compared with the placebo group. Two patients in the synbiotic group reported transient adverse events (headache). The results indicate that treatment of IBS patients with the synbiotic significantly improved all major symptoms of IBS and was well-tolerated. The ClinicalTrials.gov registration was NCT05731232.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Síndrome do Intestino Irritável
/
Simbióticos
Limite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Nutrients
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Polônia