Clinical study carried out to investigate the efficacy of two probiotic formulates on irritable bowel syndrome

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: For the study 150 adult subjects, diagnosed with irritable bowel syndrome associated to constipation (IBS‐C) were enrolled and divided in three groups (F_1, F_2, F_3). Each group received a daily oral administration of different probiotic mixtures (for a total period of 60 days). Participants are randomly allocated to one of three groups: Group 1: Participants receive probiotics mix F_1 (Lactobacillus acidophilus and Lactobacillus reuteri) capsules to take once daily for 60 days. Group 2: Participants receive probiotics mix F_2 (Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis) capsules to take once daily for 60 days. Group 3: Participants receive a placebo in the form of mix F_3 capsules to take once daily for 60 days. Participants in all groups are followed for a further period of 30 days after a follow‐up period from the last ingestion of the tested products; during this period they doesn’t take anything. CONDITION: Irritable bowel syndrome associated constipation (IBS‐C) ; Digestive System ; Irritable bowel syndrome associated constipation (IBS‐C) PRIMARY OUTCOME: 1. IBS‐C symptoms are measured using the IBS‐C questionnaire of related symptoms, which consists of five items (bloating, abdominal pain, constipation, abdominal cramps and flatulence) scored on a 10‐point Visual Analogue Scale (VAS) at baseline, 10, 30 and 60 days; 2. Gut colonization is determined through fecal microbiological analyses using species‐specific qPCR on stool samples collected at baseline, 10, 30 and 60 days SECONDARY OUTCOME: Maintenance of the obtained effects are measured using IBS‐C symptoms questionnaire microbiological analyses performed by species‐specific qPCR 30 days after the last product(s) intake. INCLUSION CRITERIA: 1. Aged between 18 and 65 years old 2. Suffering from Irritable Bowel Syndrome with constipation (IBS‐C)
Epistemonikos ID: b0ce77681f2b75fc90b71e840ada99eb5f04059e
First added on: Aug 24, 2024