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Completed

NCT Number: NCT06610149

A Novel Probiotic Mixture in Adults With IBS

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).

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Pediatrica

Bari, Apulia, 70125, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic mixture

Dietary Supplement

8 weeks treatment with Probiotic mixture

Primary outcomes

  1. abdominal pain

    Time frame: After 8 weeks of probiotic supplementation and after 4 weeks of follow-up

    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)

  2. bloating

    Time frame: After 8 weeks of probiotic supplementation and after 4 weeks of follow-up

    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).

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Acronym: IBS-dammil5

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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