Estudo de Viabilidade para Avaliar uma Sonda Transnasal de Diferença de Potencial Intestinal
The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Increased gastrointestinal (GI) permeability is associated to several GI conditions that affect millions of people worldwide. Healthy intestinal walls limit only specific molecules to cross into the body. "Leaky gut" is a condition of unregulated and increased gut permeability that allows unwanted antigens, pathogens and microbial toxins into the bloodstream(1). This in turn leads to a subsequent immune response that includes the production of inflammatory mediators. Leaky gut is a key feature in celiac disease, Crohn's disease, inflammatory bowel disease (IBD), and environmental enteropathy and have been associated with systemic diseases including type 1 diabetes, autoimmune hepatitis, and systemic lupus erythematosus (SLE).
The current gold standard for measuring intestinal permeability is the sugar ratio test. Non-metabolized sugars of different molecular sizes are orally administered and the amount of sugar molecules absorbable across the gut lining is then quantified by measuring their relative concentrations in urine. In healthy subjects, low to none of the large-molecule disaccharides can be taken into the circulatory system, while the small-molecule monosaccharides can readily diffuse into the bloodstream. This results in low disaccharide/monosaccharide (DM) ratios for healthy subjects. Subjects with the leaky gut conditions exhibit high DM ratios in their urine. However, the sugar ratio test has low specificity, does not provide specific information on etiology, is challenging to implement when pristine urine samples cannot be collected (e.g. infants), and does not account for spatially heterogeneous disease.
An alternative approach for measuring mucosal permeability is through measuring the voltage across the intestinal wall (Intestinal potential difference; IPD) that changes with intestinal permeability. The Tearney lab has developed an IPD measuring device (IPD probe) that can be deployed trans-nasally and can measure the intestinal potential difference in real time at selected locations of the gut. The probe contains a central channel that allows us to infuse specific ionic solutions into the gut. The IPD probe also has an optical fiber inside the channel that enables the acquisition of M-mode OCT images. The M-mode OCT images make it possible to determine when the IPD probe is in contact with the tissue.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Healthy subjects
- Participant must be 18 to 60 years of age
- Participant must be able to consent to the procedure
- Participant must fast (no solid food) for at least 8 hours prior to the procedure
Exclusion Criteria:
- Participants with a history of upper respiratory disease or surgery
- Participants with a history of upper gastrointestinal surgery
- Partcipants with upper respiratory infection at least 7 days prior to the procedure
- Participants with any contraindications to the placement of the NJ tube including deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc.
- Participants with a history of or being on medications that delay gastric emptying.
- Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
- Participants using nasal steroids or any steroids for environmental allergies
- Participants with suspected or diagnosed HIV
- Participants with a recent use of Antibiotics within the past 4 weeks
- Participants with a current or history of Alcoholism
- Participants with suspected or diagnosed Hep B or Hep C
- Participants enrolled in clinical trials involving interventions that affect Intestinal Permeability
- Participants with uncontrolled Diabetes Mellitus 1 & Diabetes Mellitus 2
- Participants currently taking H2 Histamine Antagonists (such as Pepcid, Axid, Tagamet, Zantac, etc)
- Participants currently taking Mast Cell stabilizers
- Participants currently pregnant.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Feasibility of trans-nasal IPD probe
The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability |
A total of 10 healthy adult volunteers will be enrolled in this study. All consented participants will be receive the same intervention. A Nasal tube will be inserted through nares until reaching the small intestine. This will be confirmed by m-mode OCT. Once secured, we will start infusing Ionic solution into the intestine so that IPD Probe can measure the potential difference between this and the control reading. The control reading is measured by infusing the same ionic solution subcutaneously on large muscle groups. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Baseline IPD readings
Prazo: The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.
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Feasibility will be measured by the IPD probes ability to, accurately and in real-time, measure voltages that are consistent with literature for the tissue we are testing |
The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.
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IPD readings after Glucose/Galactose infusion
Prazo: The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.
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the IPD probe's ability to measure a more positive reading when Glucose or Galactose have been perfused. |
The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.
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Image Quality
Prazo: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
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Image quality will be determined by our study staff's ability to discern the various tissues' architecture and morphology and the resolution of the images recorded. This is a qualitative measurement to determine feasibility of the device. |
Imaging data is collected during the procedure, and analyzed within 1 year of collection.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Guillermo Tearney, M.D, PhD., Massachusetts General Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020P000158
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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