NCT06610149

A Novel Probiotic Mixture in Adults With IBS

A Multicenter Real-World, Single-Arm, Open-Label Study Assessing the Impact of Novel Probiotic Mixture on the Symptoms of Irritable Bowel Syndrome in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,098 (actual)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Irritable bowel syndrome (IBS) is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool, however, there is no strain recommendations. This multicenter re-al-world, single-arm, open-label study aims to assess the effectiveness, safety, and patient satis-faction of a novel probiotic mixture in patients with IBS. Methods: This study is conducted by Italian gastroenterologists who enroll patients with IBS. Throughout the 8-week treatment (T1) period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lac-tobacillus plantarum 14D CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500, and Bifidobacterium animalis ssp. lactis Bi1 LMG P-17502), participants complete a questionnaire to evaluate IBS symptoms at baseline, at the end of treatment, and after one-month follow-up (T2).

Detailed description

Irritable bowel syndrome (IBS) is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool, however, there is no strain recommendations. This multicenter re-al-world, single-arm, open-label study aims to assess the effectiveness, safety, and patient satis-faction of a novel probiotic mixture in patients with IBS. Methods: This study is conducted by Italian gastroenterologists who enroll patients with IBS. Throughout the 8-week treatment (T1) period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lac-tobacillus plantarum 14D CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500, and Bifidobacterium animalis ssp. lactis Bi1 LMG P-17502), participants complete a questionnaire to evaluate IBS symptoms at baseline, at the end of treatment, and after one-month follow-up (T2).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic mixture	8 weeks treatment with Probiotic mixture

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-06-30
• Completion: 2023-08-31
• First posted: 2024-09-24
• Last updated: 2024-09-24

Locations

1 site across 1 country: Italy