Insights

Actionable results from GutTracker® tests have been identified in multiple indications

Gastroparesis Syndrome

The Gold standard test for gastroparesis is gastric emptying scintigraphy (GES), which identifies patients who have either abnormally slow or abnormally fast gastric (stomach) emptying in a 4 hour test. Patients consume a very small one-size-fits-all test meal of radioactive-labeled eggs and toast and are examined repeatedly with a high cost gamma camera. Physicians use the result to determine therapy, for example addressing slow emptying with a motility medication. GutTracker has outperformed GES in a study at the Mayo Clinic by identifying more patients with abnormal activity. We have shown that the identification is more reliable, being based multiple days of data under real world conditions where patients consume the meals that lead to their symptoms. GutTracker is also far more accessible than the GES test which means it can be used as a first line diagnostic rather than a last resort. Results have been disseminated in a published manuscript, podium presentations and award winning scientific posters at major conferences.

Chronic constipation

Patients in the Mayo Gastroparesis Syndrome study who reported constipation symptoms exhibited reduced nighttime colon activity compared to others in the study and to healthy controls. This specific signature supports the possibility of targeted intervention, for example by taking stimulants late in the day for optimum effectiveness. Further, the effect of the chosen therapy can be easily assessed by a retest, which is possible due to the user-friendliness of the system and the feasibility of sending patches to the patients for them to place on themselves. This result won the “American College of Gastroenterology Best Research in the Colon Category Award” at ACG 2024.

Crohn’s Disease

In award winning scientific posters at AGA and ACG conferences, another one noted by organizers of the CCFA Congress as of special interest and in an upcoming manuscript, we have demonstrated that Crohn’s Disease patients in flare have lower colonic and small intestinal activity than those in remission or healthy controls. This suggests that routine monitoring of CD patients might be able to predict the onset of flare before it becomes full blown, by detecting a reduction in activity from baseline. The ability to mail patch kits to patients for them to apply and carry out the test remotely makes this a feasible and attractive alternative to regular clinic visits.

Post-operative recovery from abdominal surgeries

Immediately following abdominal surgery the GI organs are typically in a quiescent state. As function returns to each organ patients become ready to consume first clear liquids, full liquids and finally solid meals, which readies them for discharge. However with no way of determining function of the organs surgeons and hospital staff must rely on indirect signals such as passing of gas, small bowel movements, or simply hunger and lack of pain. GutTracker’s ability to measure the activity of each organ in short time increments (10 minute) provides the objective information to accurately guide decisions on feeding and discharge. Rather than rely on a standard schedule for the process GutTracker allows patients to be treated as individuals with precision medicine.

In multiple published manuscripts and several more in process, we have shown that metrics such as time to discharge or to first flatus correlate with the degree of organ activity measured in just the first 12 to 48 hours, depending on procedure. Most recently at the Mayo Clinic in Florida it has been discovered that patients who went on the develop post-op ileus (POI) had abnormally strong activity in the small intestine as early as 6 hours after surgery that persisted for days.

Discoveries from GutTracker® testing about function of the digestive tract

With GutTracker’s continuous multi-day, full GI tract recordings we’ve had the opportunity to make measurements and detect phenomena that have never before been accessible to physicians or even researchers. Some of our most interesting findings follow. As we scale from roughly a thousand to hundreds of thousands of tests and more, we anticipate many more important discoveries will be made.

When the myoelectrical activity of the full GI tract is measured, each person has an individual pattern activity which we render as a GutPrint. This GutPrint consists of the frequencies and amplitudes that the stomach, small intestine and colon perform during the full 24 hour day. Surprisingly the GutPrint pattern can persist and be recognizable for as long as years, even without careful curation of the patient’s meals and activities. Yet differences from day to day can be measured, and in particular changes induced by medications can be quantified.
Reproducibility of the GutPrint requires a full 24 hours of measurement – anything shorter than that will not be consistent – much like how a heartbeat repeats faithfully but only if one measures for a full heartbeat, and nothing shorter. We use the term GutBeat to refer to the 24 hour period. Recording data for multiple GutBeats provides the most reliable data.
The gut is quite active at night, contrary to some early publications. The colon is actually more active at night than during the day in healthy controls. We have found that the ratio of night to day colon activity is tied into at least some forms of constipation, and may be a useful biomarker.
Although many (though not all) older publications refer to frequencies of rhythmic activity in the colon being primarily in the single digits, we have shown that there is a great deal of activity from 12 to 20 cycles per minute (cpm). Comparisons with data from SmartPill and manometric pressure measurements and other tests (including testing during a colonoscopy!) confirm this.
Day to day variation may in itself reflect pathology – for example patients with low gastric activity as in gastroparesis – we have found that the day to day variation is greater than for those with normal or high gastric activity.
A large proportion of the electrical signals from rhythmic contractions of the stomach, small intestine and colon reach the skin surface, despite having to propagate through substantial layers of tissue, fat and skin. In a published study with fully ambulatory mini-pigs that had internal electrodes surgically placed as well as wearing GutTracker® patches, on average over 50% of the internally measured rhythmic activity events were also recorded externally at the same times and frequencies.