Healthy
Conditions
Keywords
OCT
Brief summary
The purpose of this study is to demonstrate the feasibility of using the transnasal endomicroscopy (TNE) platform, using intestinal potential difference (IPD) and microbiome brush to evaluate the intestine of unsedated infants.
Detailed description
A total of fifteen (15) subjects, infants 6 months of age to 48 months of age will be enrolled in this study. While the subject is awake and unseated, a catheter with optical coherence tomography (OCT) imaging technology will be introduced transnasally. Images will be acquired while the tube is moved through the subject's GI tract. After imaging is complete, accessory device(s) may be threaded through the catheter to collect samples of the gut microbiome and/or measure intestinal potential difference.
Interventions
DEVICETransnasal introduction tube
Imaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe.
Sponsors
Bill and Melinda Gates Foundation
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
* 6 to 48 month old infants that can follow fasting requirements
Exclusion criteria
* Any infant under 6kg of weight since this is the minimum weight for 6.5 F nasogastric (NG) tube * Any infant whose nasal passage cannot reasonably accommodate a 6.5 French nasoduodenal catheter. * Any infants with absolute or relative contraindications to transnasal tubes: 1. severe midface trauma and recent nasal, throat, or esophageal surgery. 2. Esophageal varices, esophageal stricture, and alkaline ingestion 3. Congenital anatomical defects affecting the gastrointestinal tract, most specifically cleft lip and/or cleft palate. * Any infant with absolute or relative contraindication to a duodenal biopsy: 1. post bone marrow transplant 2. coagulation abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Acquire Intestinal Images in an Unsedated Infant | Approximate 90 minute study visit | Can the technology successfully collect images of the small intestine in an unseated infant? |
| Ability for Unsedated Infant Subjects to Tolerate the Device | Approximate 90 minute study visit | Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort? |
| Ability to Visualize Features of the Small Intestine in Unsedated Infants. | Approximate 90 minute study visit | Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants? |
| Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples | Approximate 90 minute study visit | Can the technology successfully collect microbiome brush and/or intestinal potential differences samples? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants | Approximate 90 minute study visit | Measurements including DNA load and microbial composition will be collected. |
| Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants | Approximate 90 minute study visit | Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trans Nasal Endomicroscopy Imaging The subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit.
Transnasal introduction tube: Imaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Trans Nasal Endomicroscopy Imaging |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 27 Months STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Ability for Unsedated Infant Subjects to Tolerate the Device
Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort?
Time frame: Approximate 90 minute study visit
Population: The procedure was tolerated by the study participant during insertion, imaging of the stomach and removal of the TNIT but the procedure was terminated early due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant. Tolerability could not be assessed for some portions of the study procedure including transit to the small intestine, IPD measurements and microbiome brush sample collection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trans Nasal Endomicroscopy Imaging | Ability for Unsedated Infant Subjects to Tolerate the Device | 1 Participants |
Primary
Ability to Acquire Intestinal Images in an Unsedated Infant
Can the technology successfully collect images of the small intestine in an unseated infant?
Time frame: Approximate 90 minute study visit
Population: Procedure was terminated early due to loss of the imaging signal, therefore no OCT images of the small intestines were acquired for this subject, thus this participant could not be assessed for this outcome measure.
Primary
Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples
Can the technology successfully collect microbiome brush and/or intestinal potential differences samples?
Time frame: Approximate 90 minute study visit
Population: The procedure was terminated early and target samples were not collected in the enrolled subject. Subsequently, a shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled.
Primary
Ability to Visualize Features of the Small Intestine in Unsedated Infants.
Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants?
Time frame: Approximate 90 minute study visit
Population: OCT images were acquired through the TNIT from the esophagus and stomach but the procedure was terminated early due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant. Features of the small intestine (villi etc) could not be assessed.
Secondary
Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants
Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants
Time frame: Approximate 90 minute study visit
Population: The procedure was terminated early prior to the TNIT entering the small intestine due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant and IPD measurements were not collected.
Secondary
Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants
Measurements including DNA load and microbial composition will be collected.
Time frame: Approximate 90 minute study visit
Population: The procedure was terminated early and target samples were not collected in the enrolled subject. Subsequently, a shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled.