A Novel Probiotic Mixture in Adults With IBS
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Dietary Supplement: Probiotic mixture
- Registration Number
- NCT06610149
- Lead Sponsor
- University of Bari
- 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).
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1098
- 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.
- none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Probiotic Probiotic mixture 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)
- Primary Outcome Measures
Name Time Method abdominal pain 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)
bloating 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinica Pediatrica
🇮🇹Bari, Puglia, Italy