safety and efficacy of a probiotic supplement in ibs-d

Conditions: Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome

Summary: this study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant irritable bowel syndrome (ibs-d).

this is a double-blind, randomised, placebo-controlled trial designed to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with ibs-d, when consumed orally in capsule form once daily for 84 days. volunteers will be screened in order to identify up to 134 participants meeting rome iv criteria for ibs-d. the study will involve 5 visits over a total of 105 days \[visit 1: screening, commencement of run in period (-21 to -14 days), visit 2: baseline/ randomisation (day 0), visits 3 and 4: intervention period (day 28 ± 2, day 56 ± 2), visit 5: end of study (day 84± 2)\]. participants will fill in daily and weekly ediaries, and questionnaires will be administered at study visits. faecal samples will be collected on visits 2 and 5.

Eligibility criteria:
inclusion criteria * males and females aged ≥18 to ≤ 65 years. * participants diagnosed with diarrhoea-predominant irritable bowel syndrome (ibs-d) as per rome iv criteria: i) recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria: * related to defecation * associated with a change in stool frequency (increase/decrease in frequency). * associated with a change in the form (appearance) of stool. ii) history of abnormal bowel movements predominantly diarrhoea (\>25% of bowel movements categorised as stool form type 6 or 7 (diarrhoea) and \<25% as stool form type 1 or 2 (constipation) on bsfs). * participants with an ibs-sss score ≥ 175. * participants who test negative for covid-19 by rapid antigen test device. * participants who did not change their diet within three months before the screening day and are willing to sustain that diet during the study. * participants who can comply and perform the procedures as per the protocol (consumption of study products, biological sample collection procedures, and study visit schedule). * participants who are literate enough to understand the purpose of the study and their rights. * participants who are able to give written informed consent and are willing to participate in the study. exclusion criteria * participants who score ≥ 40 in either the 'state' or 'trait' section of the stai-ad questionnaire (both sections to be assessed). * participants diagnosed with coeliac disease. * lactose intolerant participants unless on a strict lactose free diet for at least three months before screening day with persistent symptoms of ibs-d. * participants with a body mass index (bmi) ≥ 30 kg/m2. * presence of uncontrolled hypertension defined as systolic blood pressure (sbp) ≥ 140 mm hg and/or diastolic blood pressure (dbp) ≥ 90 mm hg. * participants with a history of intake of antibiotics (rifaximin, metronidazole, or any other), other probiotics, prebiotics, synbiotics, food supplements with iron or calcium, peppermint oil, acid sequestrants (cholestyramine, bile colestipol), introduced/active low fodmap diet, and histamine h2-receptor antagonists/h2 blockers within six weeks prior to the screening day. * participants with a history of daily intake of antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors (ssris), and selective serotonin-norepinephrine reuptake inhibitors (ssnris)), clonidine, otilonium bromide, asimadoline, eluxadoline, diphenoxylate, antispasmodics including mebeverine and pinnaverium and anticholinergics within two weeks prior to the screening day. * participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine. * participants with a history of gastrointestinal-related abdominal surgery other than hernia repair. * participants with a history of or complications from inflammatory bowel disease (crohn's disease or ulcerative colitis) and ischemic colitis. * participants showing signs of bile acid malabsorption (bam), as evident from the history of green colour or foul odour of the stool during the last month. * participants with a history of or complications from gi malignant tumours. * participants with a history of or complications from other malignant tumours in the last 5 years. * history of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints. * participation in other clinical studies in the last 90 days prior to screening day. * active smokers or using any form of smokeless tobacco. * participants with substance abuse problems (within two years) defined as: * use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/nicotine dependence. * high-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol-containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol-containing beverages per week for men. * participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder and other gastrointestinal diseases. * participants with active human immunodeficiency virus (hiv) or hepatitis a, b or c infection. * female participants being pregnant, breastfeeding or planning pregnancy in the course of the study. * any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Keywords: ibs probiotic irritable bowel syndrome gi microbiome bifidobacterium