An Oral Formulation of the Probiotic, Bacillus subtilis HU58, Was Safe and Well Tolerated in a Pilot Study of Patients with Hepatic Encephalopathy
Sayed Yossef,1 Frances Clark,1 Sarah S. Bubeck ,2 John Abernethy,3 Thomas Bayne, 4Kiran Krishnan,4 and Aicacia Young4
Published 30 June 2020 in the journal of Evidence-Based Complementary and Alternative Medicine
HE for short is the inability of the liver to process ammonia and is associated with loss of brain function because of high ammonia levels. Ammonia is a byproduct of protein fermentation in the gut and is a neurotoxin. Detoxification of ammonia happens in the liver during protein metabolism. In people with acute or chronic liver diseases, the liver has trouble detoxifying the amount of ammonia that comes from the gut. Consequently, the ammonia concentration in the blood rises and causes dysfunctional neurotransmission and brain swelling when it interacts with the nervous system.
Confusion, Forgetfulness, Mood swings, Changes in sleep patterns and other symptoms of HE are possible.
In this study the probiotic Bacillus subtilis HU58 was used to see if it helps reduce blood ammonia levels in patients with baseline levels >60 mcg/dL.
This is another study that indicates that Bacillus spores can support healthy liver function and detoxification, which can have a direct impact on brain function.
Patients who participated in this study all took lactulose to manage symptoms and many also took Rifaximin.
Lactulose is used by physicians as standard of care. It promotes the growth of urease-producing gut bacteria. The enzyme urease degrades ammonia and helps to clear this potential toxin from the body by causing loose stool or diarrhea.
As you can see the gut microbiome is involved in the reduction of blood ammonia and Lactulose is utilized for this process. In addition, a healthy and acidic gut aids in the reduction of ammonia absorption into the blood stream.
Researchers speculate that using probiotics, such as B. subtilits HU58, may enhance the ammonia-clearing capacity of the gut by improving microbial diversity and reducing intestinal pH.
Study Summary (read the study here)
To test this theory, researchers recruited 35 patients with hepatic encephalophathy to participate in a double-blind, placebo-controlled trial. The study group received lactulose + B. subtilis HU58 daily for 4 weeks, while the control group received only lactulose. At the end of the trial, researchers discovered that those with the highest baseline levels of ammonia saw the most significant improvements while using probiotics with lactulose.
When stratifying the patients by baseline blood ammonia levels, researchers found that the patients taking B. subtilis HU58 that entered the trial with higher baseline levels (>60 mcg/dL) saw the most significant improvement in blood ammonia levels.
Furthermore, the probiotic group had a reduction in adverse events, demonstrating that B. subtilis HU58 was well-tolerated among HE patients.
This study shows that B. subtilis HU58 used alongside lactulose is safe and effective in reducing blood ammonia in people with hepatic encephalopathy.
References can be found here