- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06702280
Evaluación de la seguridad de un suplemento de IGY en el microbioma intestinal
This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2L 1Y8
- Nimble Science
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
|
Placebo |
|
Experimental: IgY Supplement
Participants will ingest the IgY supplement on a daily basis |
Ingesting the immune supplement over the experimental period |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary Outcome
Periodo de tiempo: 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 |
Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secondary 1
Periodo de tiempo: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
|
Investigate the association or determine if changes in the small and large intestine occur and fecal microbiomes through metagenomic analysis |
Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
|
|
Secondary 2
Periodo de tiempo: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
|
To assess the bioavailability of the Muno-IgY, using the SIMBA capsule as a tool for sample collection |
Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NIMCSF316
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .