Safety and Efficacy of a Probiotic Supplement in IBS-D

Launched by THE ARCHER-DANIELS-MIDLAND COMPANY · Feb 22, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how safe and effective a specific probiotic supplement is for adults with a type of Irritable Bowel Syndrome known as IBS-D, which causes frequent diarrhea. The study aims to see if this probiotic can help reduce the severity of symptoms related to IBS-D. If you are an adult aged 18 to 65 and have been diagnosed with IBS-D, you might be eligible to participate. Key requirements include having recurring abdominal pain and abnormal bowel movements mostly characterized by diarrhea.

Participants in the trial will be asked to take the probiotic supplement and attend regular study visits. They will also need to maintain their usual diet throughout the study period. It’s important to know that there are strict criteria about who can join, such as not having certain medical conditions or being on specific medications, so those interested will need to go through a screening process. This study is currently recruiting participants, and it's a chance to potentially help improve treatments for IBS-D while contributing to research.

Gender

ALL

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.