Larazotide is a synthetic peptide developed to support gut health. It is designed to help regulate the intestinal barrier, addressing conditions linked to changes in gut permeability.
Understanding Intestinal Permeability
The lining of the gut acts as a selective barrier, allowing nutrients to pass into the bloodstream while blocking harmful substances. This barrier is maintained by structures called tight junctions, which are like seals between the cells lining the intestines. When these tight junctions become loose, the gut lining can become more permeable, a condition sometimes referred to as “leaky gut.” This increased permeability can allow undigested food particles, toxins, and microbes to pass into the bloodstream, potentially triggering inflammation and immune responses.
A protein called zonulin regulates these tight junctions. Elevated zonulin levels can increase intestinal permeability. Environmental stimuli, including dietary components like gliadin from gluten, can trigger zonulin release. This allows substances that should remain within the gut to cross into the body, potentially leading to various health concerns.
How Larazotide Works
Larazotide acts by targeting the zonulin pathway. It blocks zonulin receptors on the surface of intestinal cells, preventing the excessive opening of tight junctions that zonulin can induce.
This action helps restore the integrity of the intestinal barrier, reducing its permeability. This can lead to a reduction in inflammation and contribute to improved overall gut health. Larazotide works locally within the gut and is not absorbed into the bloodstream.
Health Conditions Larazotide May Address
Larazotide has been most extensively studied for celiac disease, an autoimmune condition triggered by gluten ingestion. Studies have shown that larazotide may help reduce intestinal damage and alleviate symptoms caused by gluten exposure, acting as an adjunct to a gluten-free diet. For instance, a 0.5 mg dose has shown an effect on reducing gastrointestinal symptoms like abdominal pain, gas, and bloating, and non-gastrointestinal symptoms such as headache and tiredness in celiac patients still experiencing issues despite following a gluten-free diet.
Beyond celiac disease, larazotide’s ability to regulate intestinal permeability suggests potential benefits for other conditions involving a compromised gut barrier. This includes Irritable Bowel Syndrome (IBS), where increased intestinal permeability is sometimes observed. It may help alleviate symptoms such as bloating, cramping, and irregular bowel movements. Research also indicates its potential for inflammatory bowel diseases like Crohn’s disease, and for certain food sensitivities, as these conditions are also linked to altered intestinal permeability.
Larazotide has also shown promise in reducing viral inflammation and limiting the spread of harmful toxins and pathogens. A small study involving children with Multisystem Inflammatory Syndrome in Children (MIS-C), a serious complication of COVID-19, found that larazotide was associated with faster resolution of gastrointestinal symptoms, quicker clearance of SARS-CoV-2 viral particles, and a more rapid return to normal activities. This suggests a broader role in conditions where gut barrier dysfunction contributes to systemic inflammation.
Safety and Future Research
Larazotide has demonstrated a favorable safety profile in clinical trials. It has been well-tolerated in studies involving hundreds of patients, with no significant drug-related adverse events reported, even at higher doses. Common side effects have been mild, including gastrointestinal issues like bloating, abdominal discomfort, and diarrhea, as well as headaches and fatigue.
While larazotide has undergone significant research, including Phase 3 clinical trials for celiac disease, it is not yet approved for widespread use. One Phase 3 trial for celiac disease was discontinued as it would have required a very large number of additional patients to achieve statistically meaningful results. Research continues into its potential applications, particularly in areas like MIS-C and long COVID, where its mechanism of action in regulating gut permeability could offer therapeutic benefits.