Irritable Bowel Syndrome Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 years or older
• People whose gas and bloating symptoms scored 55 or higher on a specific validated symptom questionnaire called the PROMIS Gastrointestinal Gas and Bloating scale
• People whose stomach pain scored 55 or higher on a specific validated symptom questionnaire called the PROMIS Gastrointestinal Belly Pain scale
• People whose anxiety score was below 10 on a standard 7-question anxiety screening tool called the GAD-7
• People with or without Irritable Bowel Syndrome (IBS); those with IBS must have symptoms that meet a recognised set of diagnostic standards called Rome IV criteria, as assessed through a specific questionnaire
• People who are able to complete daily questionnaires at least 80% of the time during a 2-week lead-in period before the trial begins
• People who are in generally good health at the time of screening, as judged by the investigator
• People who can read and understand English and agree to participate in the trial
• People who own a personal smartphone and are willing to download an app called Chloe by People Science
• People who can receive product shipments to an address within the United States
• People who are able to take part in study activities for up to 19 weeks

Who may not be able to join:

• People who do not own a smartphone, do not have internet access, or are not willing to download the required app
• People who have taken part in another clinical trial or used an investigational drug, device, or supplement within the 30 days before joining
• People currently receiving psychological therapy specifically aimed at gut symptoms, such as gut-directed cognitive behavioural therapy (CBT), gut hypnotherapy, or similar treatments for gut-brain disorders
• People who have used certain weight-management or diabetes medications known as GLP-1 agonists (such as semaglutide or tirzepatide) within the 90 days before joining, due to their known effects on gut function
• People currently receiving or who have recently received (within the last 6 months) chemotherapy or immunotherapy for cancer
• People currently using or planning to use any other digestive enzyme products, whether prescription or over-the-counter
• People who have been using medications known to significantly affect the gut (such as high-dose anti-inflammatory drugs, opioids, or certain antibiotics) every day for more than 30 days within the last 90 days, where the trial investigator believes this could affect results
• People whose use of probiotics, fibre supplements, laxatives, stool softeners, or anti-diarrhoeal products has changed significantly (dose changed by more than 50%, or started or stopped) in the last 30 days
• People currently diagnosed with Alcohol Use Disorder or Substance Use Disorder
• People who are currently pregnant, planning to become pregnant within the next 4 months, or who are breastfeeding
• People who have had weight-loss surgery or other major gut surgery that has permanently changed how their digestive system works (routine appendix or gallbladder removal is generally acceptable)
• People with underlying medical conditions that might affect digestive symptoms or interfere with study results, such as Type 1 diabetes or endometriosis (confirm with trial site)
• People who have had a stomach or gut infection in the past 4 weeks
• People who have a planned medical investigation during the study that might change their diagnosis, behaviour, or medications — for example, a colonoscopy or an upcoming specialist gut consultation
• People with a serious illness or condition that the principal investigator believes could affect their ability to participate or could affect the study results
• People with a known sensitivity or previous allergic reaction to corn, or a previous reaction to digestive enzyme supplements such as Beano or Lactaid
• People diagnosed with inflammatory bowel disease (Ulcerative Colitis or Crohn's Disease), Microscopic Colitis, Coeliac disease, or Bile Acid Malabsorption, or who have a history of small bowel or colon surgery
• People whose anxiety score on the GAD-7 questionnaire was 10 or higher at screening
• People currently following a low FODMAP diet, based on a dietary questionnaire completed at screening
• People who have followed a low FODMAP diet at any point in the last 6 months
• People who have previously tried a low FODMAP diet with no improvement in symptoms
• People who are currently on, or plan to start, a major restrictive, elimination, or structured weight-loss diet during the study
• People who are planning to make significant changes to their diet, lifestyle, or IBS medications during the study period
• People who have used antibiotics, antifungal, or antiviral medications within 2 weeks before joining the trial
• People who are planning extended travel that would interfere with taking part in the study
• People who the principal investigator does not consider suitable for participation for any other reason

Important: Always verify eligibility with the trial site directly before applying.