New Pill for Gastroparesis: Will It Work?

Gastroparesis is a common gastrointestinal disease in the United States, impacting approximately 5% of the population. Usually, in severe disease cases, simple treatment methods (medications or dietary changes) fail to improve patients’ quality of life. Therefore, more complex treatment strategies must be used, including surgical intervention.

Therefore, to facilitate severe gastroparesis treatment, a new generation electronic pill was created. Can it really make a difference?

What is gastroparesis?

Gastroparesis is a chronic neuromuscular disorder of the gastrointestinal tract characterized by impaired gastric motility and emptying in the absence of mechanical obstruction of the stomach. In other words, food moves through the stomach slower than normal.

Symptoms of gastroparesis

The most common symptoms of the disorder include:

• Nausea (92%)
• Vomiting (84%)
• Bloating (75%)
• Early satiety after meals (60%)
• Upper abdominal discomfort (46%)

These symptoms sometimes become so intense that patients may find themselves unable to live normally (work, enjoy their leisure time, etc.). If the symptoms do not subside, chronic gastroparesis usually develops. They cause dehydration and malnutrition to the patients’ organisms, which leads to hospitalization.

Causes of gastroparesis

Most often gastroparesis is considered an idiopathic disease, which means that patients experience symptoms and delayed gastric emptying but do not have any causative medical problems. Idiopathic gastroparesis is more prevalent among young or middle-aged women.

However, quite often this disease can occur as a secondary condition in patients with diabetes, Parkinson's disease, or multiple sclerosis or those who have contracted viral stomach infections (gastroenteritis). Still, diabetes is the most known cause of gastroparesis; it disrupts nerves (such as the vagus nerve) activity, which regulates the patient's digestive system.

How is gastroparesis diagnosed?

Gastroparesis is diagnosed by evaluating the patient's symptoms, medical history, physical, and medical tests results.

First of all, doctors take a look at the patient's medical history. The patient's symptoms, medications, and past and present health problems (such as diabetes, nervous system disorders, hypothyroidism, etc.) are evaluated in detail. Next, physical tests are performed. During a physical examination, the doctor usually checks the patient's blood pressure, temperature, heart rate, and signs of dehydration and malnutrition, and evaluates the abdomen for unusual sounds, tenderness, or pain.

The final diagnosis of gastroparesis is confirmed by medical tests. There are three main medical tests that help to accurately diagnose this disease:

• Radioisotope gastric-emptying scan. The patient must consume food containing very low levels of radioactive substances. A scanning machine scans the abdomen to visualize where the radioactive material is located. By tracking the radioactive material, the doctor measures how fast your stomach empties. If more than 10% of radioactive material is still in the stomach 4 hours after consuming it, gastroparesis is diagnosed.
• Gastric emptying breath test. The patient must consume a meal that contains a non-radioactive substance (13C isotope) that is absorbed by the intestines and eventually passes into the breath. By tracking 13C isotope amounts in patient breath samples (over a period of 4 hours), the doctor can know how fast the patient's stomach empties.
• Wireless motility capsule (SmartPill). The patient swallows a very small electronic device, which sends the information about digestive tract functions while traveling through it.

However, before making a final diagnosis the doctor may prescribe additional medical tests:

• Blood tests. They can show dehydration, malnutrition, blood sugar problems, etc.
• Ultrasound. This is an imaging test that helps to visualize patient stomach.
• Electrogastrography. Measures electrical activity in the patient's stomach using electrodes placed on skin.
• Gastric manometry. A thin tube is inserted through the mouth into the stomach to check stomach electrical and muscular activity.
• Upper gastrointestinal x-ray. The patient drinks a liquid containing barium, which coats the lining of the patient's upper gastrointestinal tract and helps to visualize it on x-ray.

Gastroparesis treatment

Symptomatic treatment and dietary measures are two methods that are usually used to treat gastroparesis. “Prokinetic'' medications (including erythromycin, metoclopramide, and domperidone) and anti-nausea medicines are used to reduce the symptoms of the disease. Unfortunately, these drugs demonstrate only a minimal positive effect in severe cases, and many patients hardly tolerate their side effects. In the case of dietary measures, patients need to change their diet, consume food low in fiber and fat, and eat frequent meals of small portions.

However, for the majority of gastroparesis cases, these conventional medical approaches are ineffective, thus gastric electrical stimulation should be applied.

Gastric electrical stimulation

Gastric electrical stimulation (or gastric pacemaker therapy) is an alternative treatment method for patients with drug-refractory symptomatic nausea and vomiting related to gastroparesis. This treatment method involves the placement of a gastric pacemaker under patients’ ribs (the procedure is minimally invasive and performed under general anesthesia) to stimulate stomach nerves with a mild electric current.

Scientific studies show that electrical stimulation significantly reduces the frequency of common disease symptoms, such as nausea, vomiting, early satiety, and flatulence. More importantly, the electric current not only stimulates the stomach muscles, causing them to contract but also stimulates the nervous and endocrine systems. In this way, the patient's gut-brain axis (the two-way biochemical signaling between the gastrointestinal tract and the central nervous system.) gets positive stimulus, which leads to long-lasting positive therapy effects without causing any side effects.

Although the therapy is effective, patients do not find it attractive because it requires surgical intervention, is imprecise, and requires significant recovery periods. Therefore, to facilitate the treatment of gastroparesis, a new generation electroceutical capsule was created.

Bioinspired, ingestible electroceutical pill

A team of researchers from Brigham and Women’s Hospital, Massachusetts Institute of Technology, and New York University have developed an ingestible electroceutical device that could enable non-invasive gut stimulation. According to scientists, this electroceutical pill could be used to modulate hunger levels and treat metabolic and neurologic diseases such as gastroparesis.

The developed electroceutical capsule has a hydrophilic, fluid-wicking surface with grooves where electrodes are placed. The energy for the capsule is supplied by ingestible batteries, using which electrodes are able to generate electrical stimulation for 20 minutes. This pill is able to deliver electrical stimulation directly to the stomach mucosal tissue.

Studies show that this capsule is safe to be swallowed, then successfully travels to the stomach where it delivers the stimulation, and finally is excreted safely. The most important fact which was confirmed by research is that the electrical stimulation of the pill positively regulates the amounts of the hormones needed for the proper gastrointestinal tract work. The same effect as in the case of gastric electrical stimulation therapy.

These positive results suggest that the electroceutical pill will soon be approved by the United States Food and Drug Administration (FDA) and in the near future used in the treatment of gastroparesis. But until then, patients have to trust and believe in the methods used so far. They have been applied for many years and have proven to be effective.