A Novel Probiotic Mixture in Adults With IBS

NCT06610149 | Completed DMC

• 1 other identifier: PENTA-IBS
• Study Type: interventional
• Target: 1,098
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; probiotics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Probiotic

EXPERIMENTAL

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

Interventions

Probiotic mixture DIETARY_SUPPLEMENT

8 weeks treatment with Probiotic mixture

Probiotic

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Clinica Pediatrica

Bari, Apulia, 70125, Italy

Location

Related Publications (1)

• Drago L, Corleto VD, Ciprandi G, Brindicci VF, Dargenio VN, Cristofori F, Schettini F, Mauro A, Di Marino VP, la Grasta G, Marseglia G; IBSdammil5 study group; Francavilla R. A multicenter real-world, open-label study assessing the impact of a probiotic mixture on symptoms of irritable bowel syndrome in adults. Benef Microbes. 2025 Sep 16:1-12. doi: 10.1163/18762891-bja00097. Online ahead of print.

  PMID: 40987448 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Single-Arm, Open-Label Study

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

IT (1)