Assessing the Safety of an IGY Supplement on the Gut Microbiome

NCT06702280 | Not Yet Recruiting Phase 1

• 1 other identifier: NIMCSF316
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.

Conditions

Healthy; Microbiome

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  To assess the safety of Muno-IgY™ in the small intestine. By monitoring the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Through study completion (Baseline to the end of the interventional period), an average of 6 weeks

Secondary Outcomes (2)

• Secondary 1

  Through study completion (Baseline to the end of the interventional period), an average of 6 weeks

• Secondary 2

  Through study completion (Baseline to the end of the interventional period), an average of 6 weeks

Study Arms (1)

IgY Supplement

EXPERIMENTAL

Participants will ingest the IgY supplement on a daily basis

Dietary Supplement: IgY supplement

Interventions

IgY supplement DIETARY_SUPPLEMENT

Ingesting the immune supplement over the experimental period

IgY Supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent; willing and able to comply with study procedures.
• Willing to maintain their diet and physical activity levels during the study.
• Able to swallow a 25mm x 9mm sized capsule

You may not qualify if:

• 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.
• 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.
• History of known structural gastrointestinal abnormalities such as structures or fistulas which may lead to mechanical obstruction.
• 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.
• Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
• 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.
• Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).
• History or diagnosis of immunological or infectious disease (hepatitis, tuberculosis, HIV, Parkinson's).
• History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
• Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
• Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
• Any prior Fecal Microbiota Transplantation.
• Colon cleanses/bowel prep for 2 weeks
• Pregnant or breastfeeding.
• Planning to become pregnant.

Sponsors & Collaborators

• Nimble Science Ltd.: lead
• IGY Immune Technologies & Life Sciences Inc.: collaborator

Study Sites (1)

Nimble Science

Calgary, Alberta, T2L 1Y8, Canada

Location

Central Study Contacts

Gwen Duytschaever Duytschaever, PhD

CONTACT

8664934633; clinical@nimblesci.com

Isaac Wong, MBT

CONTACT

8664934633; clinical@nimblesci.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 22, 2024
• Study Start: February 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)