Type 2 Diabetes Trial, Recruiting

Written by an AI model from the 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 between 18 and 65 years of age
• People with a confirmed diagnosis of type 2 diabetes, recorded in their medical history using standard diagnostic guidelines
• People whose HbA1c blood sugar level (a 3-month average blood sugar measure) falls between 6.8% and 8.2% at the screening appointment, tested at a certified laboratory
• People with a body mass index (a measure of weight relative to height) between 18.5 and 40.0 at screening
• People who have been on the same diabetes medications for at least 3 months before joining, limited to metformin, a DPP-4 inhibitor, and/or an SGLT2 inhibitor (alone or combined)
• People whose body weight has been stable, meaning it has not changed by more than 5% or 3 kg (whichever is the smaller amount) in the 3 months before screening
• People who are willing and able to give written consent to participate
• People who are willing and able to attend trial visits, use the study product, and provide fasting blood and stool samples as required by the study schedule
• People willing to receive standard lifestyle advice during the 24-week blinded study period and to keep their diabetes management stable as directed by their doctor
• People who have not used antibiotics in the 8 weeks before joining
• People who have not used probiotic, prebiotic, synbiotic, or postbiotic supplements in the 8 weeks before joining
• People with stable high blood pressure, high cholesterol, or stable thyroid hormone treatment are eligible, provided those medications have been at the same dose for at least 3 months before joining

Who may not be able to join:

• People with type 1 diabetes, autoimmune diabetes, diabetes caused by pancreas damage, a rare inherited form of diabetes, gestational diabetes, or any form of diabetes other than type 2
• People whose HbA1c blood sugar level is below 6.8% or above 8.2% at screening
• People who are currently using, or have used within the past 12 months, a GLP-1 receptor agonist or GLP-1/GIP co-agonist medication (a type of injectable or oral diabetes or weight-loss drug)
• People who are currently using insulin of any kind, or who have used insulin in the past 6 months
• People who are currently using, or have used in the past 3 months, sulfonylurea or meglitinide diabetes medications
• People who are currently using, or have used in the past 6 months, any prescription weight-loss medication (including orlistat, naltrexone/bupropion, phentermine/topiramate, or similar drugs)
• People who have experienced repeated serious low blood sugar episodes or who cannot feel the warning signs of low blood sugar
• People whose treating doctor plans to start or increase any diabetes medication, weight-loss medication, or steroid medication during the 24-week trial period
• People who have had weight-loss (bariatric) surgery at any point in their life
• People who have had bowel or stomach surgery, other than removal of the appendix or an uncomplicated gallbladder removal
• People with active inflammatory bowel disease, coeliac disease, microscopic colitis, long-term pancreatitis, a condition affecting nutrient absorption, or any serious ongoing gut condition likely to affect the study
• People who have had a stomach or gut infection in the 4 weeks before joining
• People who have had a colonoscopy bowel preparation procedure in the 12 weeks before joining
• People who have received a faecal microbiota transplant (a gut bacteria treatment) in the 12 months before joining
• People with an active cancer diagnosis or who have had cancer treatment in the past 6 months, except for certain treated non-melanoma skin cancers
• People with significantly reduced kidney function (confirm with trial site)
• People with serious liver disease (confirm with trial site)
• People with certain elevated liver enzyme levels on blood tests at screening, unless the trial investigator reviews and approves participation
• People with a known blood condition that affects the accuracy of HbA1c testing
• People who have had a blood transfusion, significant blood loss, or red blood cell-stimulating treatment in the 3 months before joining
• People with untreated thyroid disease, or whose thyroid medication was started or changed in the past 3 months
• People who have used steroid medications (taken by mouth or injection) in the 4 weeks before joining
• People who have used immune-suppressing or immune-modifying medications recently (confirm with trial site for timing)
• People who are pregnant or breastfeeding, or women who could become pregnant and are not willing to use effective contraception during the 24-week blinded study period
• People with a serious mental health condition or significant cognitive difficulty that could affect their ability to consent, stay safe, or follow the study requirements
• People with an active eating disorder, including anorexia nervosa, bulimia nervosa, or binge-eating disorder, or who screen positive for eating disorder concerns at the screening appointment
• People with heavy alcohol use or an active substance use disorder
• People currently following a very low-calorie diet, ketogenic diet, medically supervised weight-loss diet, or any highly restrictive diet that cuts out major food groups
• People who currently smoke and plan to try to quit during the 24-week trial period, or who have recently started nicotine replacement or quit-smoking medication within the past 3 months
• People who have taken part in another interventional clinical trial in the 30 days before screening
• People with a known allergy or significant intolerance to any ingredient in the study product or placebo
• People who are unable or unwilling to provide stool samples
• People with any other condition that the trial investigator believes would affect their safety or the reliability of the trial results

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