Page 24 - IMCJ April 2020

ORIGINAL RESEARCH

Efficacy of Spore Forming Bacilli Supplementation in Patients

with Mild to Moderate Elevation of Triglycerides: A 12 week,
Randomized, Double-Blind, Placebo Controlled Trial

Andrew W. Campbell, MD; Drew Sinatra, ND; Zhiwei Zhang, PhD, Stephen T Sinatra, MD

Abstract
Objective: The purpose of this randomized double-blind randomized to receive oral probiotic supplement
placebo controlled clinical trial was to evaluate the effects consisting of two capsules containing 5 different spore
of a commercial spore-based probiotic supplement forming bacilli once daily in the morning or a placebo
consisting of 5 different spore forming bacilli (Bacillus (rice flour). Their non-fasting triglyceride levels were
indicus HU36, Bacillus subtilis HU58, Bacillus coagulans measured again at six weeks and at twelve weeks.
SC-208, Bacillus licheniformis, and Bacillus clausii SC-109) Results: Compared to the placebo group, participants
on reducing the triglyceride levels (TG) in patients with in the probiotic supplement group had significant
mild to moderate hypertriglyceridemia (HT). lowering of their triglyceride levels after 90 days.
Study design: A randomized, double-blind, placebo- Conclusion: Mild to moderately elevated triglyceride
controlled study with eighty participants with levels can be lowered in patients with mild to moderate
non-fasting triglyceride levels greater than 150 mg/dL. HT by a probiotic supplement consisting of five different
Methods: Eighty participants with non-fasting spore forming bacilli.
triglyceride levels greater than 150 mg/dL were

Andrew W. Campbell, MD, is Medical Director of Cardiovascular diseases (CVD) have been linked to
Mymycolab in Land O Lakes, Florida. Zhiwei Zhang, PhD, triglycerides. Cholesterol and triglycerides are basically
is in the Department of Statistics-University of California insoluble in plasma. Whereas cardiovascular risk factors
6-8
Riverside, in Riverside California. Drew Sinatra, ND, LAc, have mainly focused on HDL-C, less interest has been
is a naturopathic doctor of integrative medicine at the applied to triglycerides. Elevated levels of triglycerides are
CLEAR Center for Health in Mill Valley, California. linked with low levels of HDL-C; in other words, an
Stephen T. Sinatra, MD, FACC, is an assistant clinical inverse relationship. An early report on the link between
2
professor of medicine at the School of Medicine, CVD and triglycerides was by Albrink in 19599. This
University of Connecticut in Farmington, Connecticut. study revealed that HT was more important than
hypercholesterolemia in link between CVD risk factors in
Corresponding author: Andrew W. Campbell, MD men. Data from Framingham indicated that HT was an
E-mail address: immunedoctor@gmail.com even greater risk factor for CVD in women. A number of
10
other publications have replicated these findings. 11-14
Introduction Extremely elevated triglycerides (more than 10 mmol/l)
Hypertriglyceridemia (HT) is common and present indicate increased risk for pancreatitis and lipemia
in about a third of the population. HT leads to an increase retinalis. It is established in the medical literature that
1
in atherogenic LDL levels and a lowering in HDL. extremely elevated triglycerides not provoked by
2
HT may also increase atherogenesis by the release of free nutritional factors are more likely to have a monogenic
fatty acids, the production of fibrinogen, coagulation cause. Mildly to moderately elevated triglycerides are
factors, and proinflammatory cytokines. Most often caused by polygenic disorders. Highly elevated
3
epidemiological studies indicate that HT is associated with triglyceride levels can also cause fatty liver disease, and are
obesity, diabetes, metabolic syndrome, and coronary associated with kidney disease, and the use of some
artery disease. Publications have clearly demonstrated that medications. 15
HT is strongly linked with atherosclerosis and an increased Triglycerides (TG) are mainly produced in the liver
risk for acute pancreatitis. Several clinical studies have and the intestinal tract. Cholesterol and TG are mostly
4
revealed that reducing triglycerides lowers the risk for insoluble in plasma and are transported in lipoprotein
coronary artery disease. particles consisting of a main core of cholesterol esters and
3
A 2009 study showed that the prevalence of HT was TG. Chylomicrons contain mainly TG in their core, and
54.3% in patients recently diagnoses with diabetes. chylomicrons and VLDL are the main carriers of TG in
Patients with type 2 diabetes commonly have HT. 4,5. plasma and are the two largest classes of lipoproteins. TG

22 Integrative Medicine • Vol. 19, No. 2 • April 2020 Campbell—Spore Forming Bacilli Supplementation for HT