Assessing the Safety of an IGY Supplement on the Gut Microbiome

Launched by NIMBLE SCIENCE LTD. · Nov 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a supplement called Muno-IgY to see if it can help improve immune health in healthy adults over a six-week period. The researchers want to find out how this supplement affects the gut microbiome, which is the community of bacteria in our digestive system that plays an important role in our overall health.

To be considered for this study, you must be between 18 and 65 years old and able to swallow a capsule about the size of a large vitamin. You will need to agree to keep your usual diet and exercise routine during the trial. However, if you take certain medications, have had specific gastrointestinal issues, or have other health conditions, you may not be eligible. Participants will take the supplement for six weeks and will be monitored to ensure safety and gather information on its effects. It’s essential to know that the study is not currently recruiting, so if you are interested, you will need to wait until it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-65 years old at the inclusion of the study, both female and male subjects.
• • 2. Signed Informed Consent; willing and able to comply with study procedures.
• • 3. Willing to maintain their diet and physical activity levels during the study.
• • 4. Able to swallow a 25mm x 9mm sized capsule
• Exclusion Criteria:
• • 1. Use of regular prescription medications, including antihypertensives, anti-inflammatory drugs, corticosteroids, immunosuppressants, antidepressants, antipsychotics, anti-diabetic medications, and anti-arrhythmic agents, which in the opinion of the investigator, would adversely affect study safety or outcome.
• • 2. Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
• • 3. History of known structural gastrointestinal abnormalities such as structures or fistulas which may lead to mechanical obstruction.
• • 4. Use of any medications in the week prior to the SIMBA or LIMBA capsule ingestions, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, GLP-1 analogues); laxative and prokinetic use is allowed if it is kept unchanged in the week prior to the SIMBA and LIMBA capsule ingestions. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the capsules and PPI treatment is resumed only 4 hours thereafter.
• • 5. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
• • 6. Any significant gastrointestinal, heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.
• • 7. Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).
• • 8. History or diagnosis of immunological or infectious disease (hepatitis, tuberculosis, HIV, Parkinson's).
• • 9. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
• • 10. Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
• • 11. Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
• • 12. Any prior Fecal Microbiota Transplantation.
• • 13. Colon cleanses/bowel prep for 2 weeks
• • 14. Pregnant or breastfeeding.
• • 15. Planning to become pregnant.
• • 16. Alcohol or drug abuse.
• • 17. Egg allergy
• • 18. Vegan diet, or other diet where ingestion of eggs is not suitable
• • 19. History of less than 3 bowel movements per week.
• • 20. Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed