The Safety of Capsules Containing OMX Lactic Acid Bacilli
By: Iichiroh Ohhira, Ph.D., October 2000
The population in Malaysia uses various types of health and food supplements. These products are considered safe and are used without any concern for their toxicity. Among the products used as health supplements are products that contain lactic acid bacteria. This project studied the acute and subacute toxicity of a product containing minerals, herbs, vitamins and live lactic acid bacteria, on Sprague-Dawley rats. Acute toxicity was tested 24 hours after a single dose and subacute toxicity was studied 24 hours after 7 days of daily dosing. The parameters that were studied were alanine aminotransferase (ALT. SGPT), aspartate amnotransferase (AST, SCOT) serum urea, ratios of weight of kidney and liver weight to body weight and percentage changes in body weights. The contents of capsules of the product (6, 8 or 10 capsules for acute studies and 6, 10 and 12 for subacute studies) were mixed with corn oil and fed orally to rats. Control rats were fed with corn oil alone. In the acute studies, the level of ALT in the rats treated with the contents of the capsule was lower than controls. There were no significant changes in the other parameters of the rats in the treatment groups as compared to controls. There were no significant differences in all the parameters between rats in the treatment groups as compared to controls in the subacute studies. Sprague-Dawley rats fed with high doses of the product did not show signs of toxicity in the parameters that were studied.
Products containing lactic acid bacteria have long been available in the market. They may be in the form of food such as yogurt (thairoo. dadih) or they may be marketed in pharmaceutical formulations such as capsules and liquids. In the last decade or so, with increasing interest in natural foods, the number of such products has increased.
Although the use of such products either as food or as health supplements is quite widespread, there is not much information available regarding the presence or absence of toxicity of such preparations. Some may be tempted to say "but, these are natural products!" however, it must be borne in mind that some of the most powerful toxins known to man are natural substances. Therefore, natural does not equal safe. In this study we looked at the acute and sub-acute toxicity of probiotics OMX capsules, a product containing live lactic acid bacilli, minerals, herbs and vitamins.
MATERIALS AND METHODS
OMX Malaysia Sdn Bhd supplied OMX probiotic capsules.
Male Sprague-Dawley rats weighing about 220-25Og and aged between 53 to 58 weeks were purchased from the Institute of Medical Research and housed in the pharmacology laboratory of the Pharmacy Department. Faculty of Allied Health Sciences, UKM. The ALT, AST and serum urea assays were carried out using the Reflotron dry chemistry analyser and the corresponding test strips purchased from Roche Diagnostics Sdn Bhd. Blood was collected using heparinised capillary tubes.
The contents of the OMX probiotics capsules were suspended in corn oil and the animals were fed using a syringe and a feeding needle. In the acute toxicity studies, the animals were fed one dose of the product and then they were sacrificed after 24 hours. There were 4 groups of animal; they were the controls that were fed just corn oil, the treatment group that were fed the contents of 6 capsules, 8 capsules or 10 capsules. Each group had 5 rats.
In the sub-acute toxicity studies. the animals were fed the product once a day for 7 days and then sacrificed on the 8th day. In these studies also, there were 4 groups of rats, the control group that was fed corn oil, the treatment groups that were fed the contents of 6 capsules, 10 capsules or 12 capsules.
The animals were sacrificed by cervical dislocation 24 hours after the last dose was fed. The viscera were opened and the liver and kidneys removed rinsed, blotted dry and weighed. Blood was collected in heparinised tubes and a drop placed on the test strips and the readings obtained from the Reflotron dry chemistry analyser.
In the acute toxicity studies, there was a significant decrease as compared to controls in the ALT levels of the rats fed with OMX probiotics capsules. However, no dose-related effects were observed. There was no significant differences in ALT levels between rats in the control group and treatment groups in the sub-acute studies. No differences were observed in ALT levels between rats in the control group and treatment groups in the sub-acute studies.
No differences were observed in AST levels of rats between any of the groups in both the acute as well as sub-acute toxicity studies. No differences were observed in serum urea levels of rats between any of the groups in both the acute as well as the sub-acute toxicity studies. The ratio of weight of kidney and liver to body weight was not different between all groups of rats in both the acute as well as the sub-acute toxicity studies.
In the acute toxicity studies, there was a trend towards a decrease in body weight in the treatment group rats as compared to the rats in the control group. In the sub-acute studies, however, the trend was towards an increase in body weight of the rats in the treatment groups as compared to the control rats, after 7 days of treatment. However, these differences were not statistically significant.
There were some changes in the fur of the animals fed the higher doses of the product. Diarrhea was seen in the rats fed with corn oil (control) after the first day of feeding.
The sale of health supplements was until recently on the increase. Consumers with extra cash to spend did not mind spending a little extra on health supplements "hoping" that they would help to keep them healthy. Another reason for the popularity of health supplements was that they were considered as "natural" and therefore safer than the synthetic drugs and vitamins. This opinion stems from a belief that all things chemical or synthetic are toxic and harmful. Such generalization is not safe because some of the most toxic substances are "natural", such as botulinum toxin and aflatoxin.
Products containing lactic acid bacteria have been available for a long time. Initially they were home produced products, but more recently they have been made into pharmaceutical dosage forms such as capsules. One such product is the OMX probiotics capsule that contains a mixture of minerals, vitamins, and herbs and live lactic acid bacteria.
The product is approved by the Ministry of Health as a health supplement. Among the effects that have been reported for the product include action against MRSA, restoration of gut flora, treatment of hypercholesterolemia, hepatic encephalopathv and gut infections. There have been anecdotal reports of patients, in certain instances, taking more than a few capsules a day. Being a "natural" product, the possible toxicity of the product is often not considered especially since the ingredients have been part of our native foods. However, large numbers of live bacteria in a capsule can have different effects from the amounts found in foods and so it is important to study the toxicity of these products.
Our results show that there is no significant toxicity of OMX probiotic capsules in rats, even at the extremely high doses that were used. While an increase in the levels of the hepatic enzymes ALT and AST are indicators of liver damage, a reduction in the levels of activity of these enzymes do not necessarily mean a beneficial effect on the liver. The absence of any effect on serum urea levels indicates that there may not be any toxic effect on the kidney. These results taken together with an absence of changes seen in the ratio of kidney and liver weight to body weight as compared to controls indicates an absence of toxicity in the kidney and liver.
The rats in the treatment groups as compared to the control rats showed a reduction in body weight in the acute toxicity studies, while they increased in body weight in the sub-acute toxicity studies. This trend may indicate that in the first day of feeding with the contents of the OMX capsules the rats may not have eaten as well as the control rats, but, with repeated feeding an adaptation was made, such that after 7 days they were eating as well as the controls.
The results of this study show that, for the parameters that were studied, products containing live lactic acid bacteria, such as OMX probiotic capsules, do not produce toxicity in Sprague-Dawley rats.
Superiority of Probiotic OMX Capsules
Dr. Lawrence Wong Clinical Nutritionist from Brisbane, Australia says it is unfortunate that modern medicine does not pay much attention to the many benefits of taking probiotics. He says that this is also despite the fact that about 100 years ago Dr. Elie Metchnikoff, of the Pasteur Institute in Paris, and a Nobel Prize recipient, firmly advocated the use of probiotics for their beneficial effects. He believes we now have enough knowledge to justify the taking of probiotics on a daily basis for health promotion, disease prevention and therapy.
He goes on to say that since the work of Dr. Metchnikoff, many outstanding researchers have contributed to this growing pool of probiotic knowledge. One such person whose contribution is now widely recognized is DR. IICHIROH OHHIRA. Dr. Ohhira first encountered lactic acid bacteria about 20 years ago while working in Malaysia. This led him to his doctoral dissertation: "Distribution and Biochemical Properties of Lactic Acid Bacteria from Traditional Fermented Foods in Southeast Asia". Using this research knowledge he formulated a very superior probiotic extract which he also encapsulated and now known to us as Probiotics OMX.
Dr. Wong talks about the four things to look for when choosing probiotic products:
- Methods of prepara tion
- Contents of product
- Packaging of product
- Health/therapeutic benefits
He explains the short comings of LIQUID PREPARATIONS such as yogurts which cannot be considered superior products. Unless you make your own yogurt using the right starter cultures and consume it almost immediately, you cannot rely on commercial preparations for health benefits. They often contain additives, preservatives, flavorings and other ingredients that may be allergenic. The contents may be contaminated, and damaged by centrifugation and pasteurization.
He explains that bacteria in liquid preparations have a very short shelf life and when taken in are damaged by stomach acid. They are not suitable for transport and storage. He reminds us that after centrifugation, antibacterial, antiviral, antifungal, anticholesterol and other beneficial factors in the fermentation medium are separated and discarded.
He considers FREEZE-DRIED POWDER that can be purchased as tablets or capsules. Centrifugation removes many beneficial factors in the fermentation medium. Freeze drying damages bacterial cell wall, thus he does not think that they represent a superior product. When the powder is added to water it must be consumed immediately as the bacteria tend to damage quickly. Exposure to air and humidity can also damage the powder. While you can transport the powder refrigeration is necessary. The powder may contain chemical additives.
Why is Probiotic Unique?
Dr. Wong explains: The preparation of Probiotic is most uniquely carried out. According to Dr. Ohhira, 92 kinds of natural ingredients are used, taken from natural plants from a non-polluted environment. The final product has undergone 5 years of natural fermentation process. The product contains 18 amino acids, 9 vitamins, 5 minerals and 12 types of friendly bacteria of proven benefits to human health.
Research carried out by Dr. Ohhira shows that his lactic acid bacteria has proteolytic activity 6.6 times stronger than ordinary bacteria. The packaging of the fermented extracts is most uniquely done. Unlike the liquid preparations and powder, Probiotic OMX extract is in the form of a vegetable paste packaged in a soft capsule also of vegetable matter. Those of vegetarian leaning will find this preparation most beneficial. Note some unique features of Probiotic OMX - No freeze drying and no centrifugation, 100% organic being totally of vegetable origin, and no added chemical additives. When you travel you can easily carry the capsules with you without refrigeration, as long as you keep them from the sun and heat.
The bacteria are viable and taken in an empty stomach with a glass of filtered water, the capsules are delivered to the intestines, therefore bypassing the acidic stomach. Encapsulated this way contamination is almost impossible.
Is Probiotic OMX Beneficial?
Dr. Ohhira has carried out study at Okayama University on 1250 people with different ailments and shows that Dr Ohhira's Probiotics OMX capsules have wide range therapeutic benefits. He reported antibacterial activity against Methicillin-resistant Staphylococcus aureus, and its beneficial effects on athletes.
Probiotic OMX is effective against H. pylori, the causative agent of stomach ulcer.
Probiotic OMX is also effective against E. Coli 0157, which causes food poisoning. Many people like you have benefited from taking Probiotic OMX regularly.
Dr. Wong tells how he was introduced to Dr. Ohhira's probiotics twelve plus in 1995 while working as a gastroenterology scientist. He says "In my present work as a clinical nutritionist, I always aim to optimize people's health. The place to start with is the digestive system. Most people do not realize that they have a less than healthy digestive system. I have seen and helped many people with different digestive problems using probiotic therapy. I do not claim that other systems of the body are less important and that are no other effective therapies. I affirm that a good digestive system is foundation to your health and that taking Probiotic OMX daily plays an important role.
If you have digestive disorders, you need to take therapeutic dose of at least 10 to 15 or more capsules per day to deliver major benefits. This you should do for at least four weeks and observations taken. Because taking Probiotic OMX capsules can help to resolve toxic bowel, taking it long term will promote antiaging. For health maintenance I recommend 2 to 5 capsules per day."