Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan

Study Overview
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Brief Summary
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This pilot study will test the feasibility and tolerability of the tethered OCT capsule and Trans Nasal imaging probe for imaging the small intestine in subjects with EED and a matched non-EED cohort. This study will assess subject tolerability, optimal imaging technique, and imaging of EED features.

Detailed Description
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The laboratory has developed a minimally invasive screening method known as tethered capsule endomicroscopy (TCE) for imaging intestinal mucosa. With TCE, an unsedated subject swallows a tethered pill, which captures microscopic images of the entire esophagus, stomach, and small intestine, as it is naturally transits these organs via peristalsis and under the influence of gravity. The capsule implements a microscopic imaging technology called optical coherence tomography (OCT) that obtains 10-µm-resolution cross-sectional images of tissue. The procedure is brief, well tolerated, and can be much less expensive than endoscopy. The Investigators have implemented TCE for imaging the upper gastrointestinal tract of adults and adolescents with Celiac Disease (CD) and eosinophilic esophagitis (EoE), inflammatory conditions that are common in the US. The qualities seen thus far in their TCE studies - high imaging resolution, comprehensive tissue assessment, and minimal invasiveness - are also the qualities needed for evaluating the intestinal mucosa in populations with EED. The Tearney Lab has also developed a new technique of deployment, Trans Nasal Endomicroscopy (TNE). The TNE catheter comprises of an introduction tube, similar to a standard Nasojejunal tube, with one or two balloons attached at the distal end. These balloons are inflated with Galinstan, a safe liquid metal alloy used in pediatric thermometers, which provides weight for the device to move to the duodenum under the forces of gravity and peristalsis. Alternatively, a sugar water mixture /saline may also be used to inflate a balloon. The TNE catheter encloses the OCT optics within, and is designed to have many of the same imaging properties of TCE but is introduced Trans nasally so that it can be effectively used in children and eventually infants.

Official Title
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Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan

Conditions
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Environmental Enteric Dysfunction

Intervention / Treatment
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* Device: Tethered Capsule Endomicroscope/Trans Nasal Endomicroscope


Participation Criteria
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Eligibility Criteria
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The Inclusion Criteria: EED subjects Subjects must be 6 months-18 years old EED manifesting as malnourishment (WHZ<-2) without clear etiology Subjects and/or parents/guardians must be able to give informed consent/assent Healthy Subjects Subjects must be 12-18 years old Subjects should have WHZ >=0 Subjects and/or parents/guardians must be able to give informed consent Tethered Capsule Exclusion Criteria: Subjects with any history of esophageal or intestinal strictures or prior GI surgery Subjects with history of pyloric stenosis Subjects with HIV diagnosis Trans Nasal Exclusion Criteria: Subjects with any contraindications for NG/NJ tube placement, including but not limited to those listed below: Subjects with any history of esophageal or intestinal strictures or prior GI surgery Subjects with history of pyloric stenosis or atresia Subjects with HIV diagnosis Subjects with any history of esophageal or intestinal strictures or prior GI surgery Subjects with history of pyloric stenosis Subjects with HIV diagnosis Subjects with a history of upper respiratory disease or surgery Subjects with a history of upper gastrointestinal surgery including fundoplication. Subjects with upper GI obstruction Subjects with short bowel syndrome Subjects with upper respiratory infection at least 7 days prior to the procedure Subjects 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. Subjects with a history of or being on medications that delay gastric emptying. Patients on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders. Subjects with upper GI bleeding Subjects using nasal steroids or any steroids for environmental allergies.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility of TCE and TNE<br>Feasibility is measured by the number of participants that we have successfully deployed the Trans-nasal imaging device/Tethered capsule device in. | Device: Tethered Capsule Endomicroscope/Trans Nasal Endomicroscope<br>* All particpants are asked to swallow our capsule device. If swallowed the capsule will naturally be moved to the duodenum via peristalsis. Once there we will slowly move the tether on the capsule up and down to gain OCT images of the duodenum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of TCE and TNE | Feasibility is measured by the number of participants that we have successfully deployed the Trans-nasal imaging device/Tethered capsule device in. | up to 3 hours during the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EED, Tethered Capsule Endomicroscopy, Optical Coherence Tomography, Pakistan, Intestinal Disorder