A Novel Probiotic Mixture in Adults With IBS (IBS-dammil5)

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

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Probiotic mixture

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).

• Study Type: Interventional
• Enrollment (Actual): 1098
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Puglia
    • Bari, Puglia, Italy, 70125
      • Clinica Pediatrica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• recurrent abdominal pain at least once per week during the past three months associated with two or more of the following criteria:
• related to defecation,
• Associated with a change in the frequency of stool,
• Associated with a change in the appearance of stool.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; 8-week treatment period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lactobacillus 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)	Dietary supplement: Probiotic mixture; 8 weeks treatment with Probiotic mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abdominal pain	abdominal pain severity. The questionnaire utilized a 5-point Likert scale, where 0 represented the absence of symptoms, and 5 indicated the presence of highly intense symptoms. Treatment success will be defined as a change towards categories of lower IBS severity for abdominal pain and/or bloating 149 between inclusion (T0) and the end of the supplementation period (T1)	After 8 weeks of probiotic supplementation and after 4 weeks of follow-up
bloating	bloating severity. The questionnaire utilized a 5-point Likert scale, where 0 represented the absence of symptoms, and 5 indicated the presence of highly intense symptoms. Treatment success will be defined as a change towards categories of lower IBS severity for abdominal pain and/or bloating 149 between inclusion (T0) and the end of the supplementation period (T1).	After 8 weeks of probiotic supplementation and after 4 weeks of follow-up

Collaborators and Investigators

• Sponsor: University of Bari

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: probiotics; irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: PENTA-IBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No