HealthyPhase 1/2NCT06702280
Assessing the Safety of an IGY Supplement on the Gut Microbiome
A Phase 1/2 study testing IgY supplement in people with Healthy and Microbiome, run by Nimble Science Ltd. at 1 site in Canada.
Trial summary
This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Microbiome
- What is being tested?
- IgY supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2026to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65 years old at the inclusion of the study, both female and male subjects.
- 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
Who cannot join
- 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.
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- 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.
- Alcohol or drug abuse.
- Egg allergy
- Vegan diet, or other diet where ingestion of eggs is not suitable
- History of less than 3 bowel movements per week.
- Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed
Trial locations and contacts
1 site in 1 country.
About this study
This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.
Read the detailed description
The goal of this single-arm interventional trial is to evaluate the safety and effectiveness of Muno-IGY in a sample population of 20 healthy adults over a six week period. The intervention will be compared to a baseline before ingestion of the supplement with both qualitative questionnaires, a daily diary, and microbiome data gathered by the SIMBA and LIMBA capsules.
- Conditions
- Healthy, Microbiome
- Being tested
- IgY supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgY supplementDietary supplement
Ingesting the immune supplement over the experimental period
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| IgY Supplement | Experimental | Participants will ingest the IgY supplement on a daily basis Receives: Dietary Supplement: IgY supplement |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
Secondary outcomes (2)
Secondary 1
Investigate the association or determine if changes in the small and large intestine occur and fecal microbiomes through metagenomic analysis
Measured: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
Secondary 2
To assess the bioavailability of the Muno-IgY, using the SIMBA capsule as a tool for sample collection
Measured: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study startJan 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: Sponsor cancelation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nimble Science Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702280
- Sponsor's protocol ID
- NIMCSF316
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety of an IGY Supplement on the Gut Microbiome
- ClinicalTrials.gov ID
- NCT06702280
- Acronym / sponsor ID
- NIMCSF316
- Conditions
- Healthy, Microbiome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor cancelation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nimble Science Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.
Detailed description
The goal of this single-arm interventional trial is to evaluate the safety and effectiveness of Muno-IGY in a sample population of 20 healthy adults over a six week period. The intervention will be compared to a baseline before ingestion of the supplement with both qualitative questionnaires, a daily diary, and microbiome data gathered by the SIMBA and LIMBA capsules.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IgY Supplement | Experimental | Dietary Supplement: IgY supplementParticipants will ingest the IgY supplement on a daily basis |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years old at the inclusion of the study, both female and male subjects.
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgY supplementIngesting the immune supplement over the experimental period | Dietary supplement | IgY Supplement |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Primary Outcome
Time frame: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
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
2 secondary outcomes
Secondary 1
Time frame: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
Secondary 2
Time frame: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IgY supplement in people with Healthy and Microbiome, run by Nimble Science Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.