Application of TSO®

Instructions for Use

Please read the following instructions carefully. They provide information that it is important to understand before taking TSO®.

The product

TSO® is a probiotic supplement that has been shown to help in the treatment of immune-related disorders.
It is available in bottles containing 500, 1000 or 2500 live ova of the porcine (pig) whipworm, Trichuris suis.

All bottles hold 15 ml of an isotonic, phosphate-buffered saline solution at pH 2.4, containing very small quantities of each of the following salts per 2L of distilled water:

* 0.6 g of potassium chloride (KCl)
* 11g of sodium chloride (NaCl)
* 16g of sodium phosphate monobasic dihydrate (NaH2PO4*2H2O)

Suspended in the solution in each bottle of TSO® are minute, barely visible Trichuris suis eggs that are referred to as ova, hence the abbreviation, “TSO®“.

The strain of TSO® used by Tanawisa was originally sourced from the United States Department of Agriculture farms in Baltimore, Maryland, and was used in the studies by Weinstock et al, and in all other clinical trials in humans.

Since this species of helminth is not adapted to living in humans, it dies approximately 14 days after ingestion. Following this, its remains are completely digested, leaving no eggs or young worms to be excreted by the host.

Mode of action

During its short time in the body, the immature Trichuris suis organism hatches from its egg and begins to grow, all the while shedding molecules that modulate its host’s immune system and provide a legitimate target for the host’s immune mechanisms to attack. This effectively keeps the immune system busy and prevents it from responding inappropriately to innocent targets such as foods, pollens and the host’s own tissues, as happens in autoimmune diseases such as ulcerative colitis, Crohn’s disease, multiple sclerosis, rheumatoid arthritis, contact allergies, food allergies, juvenile diabetes type 1, lupus erythematosus and sarcoidosis.

Therapeutic response to TSO®

The conditions that appear to respond best to TSO® are Crohn’s disease, ulcerative colitis, autism and lupus. TSO® can also be effective in food allergy, contact allergy, rheumatoid arthritis, multiple sclerosis and lichen planus, and it is worth trying for any autoimmune disease, or any condition with an inflammatory component.
Due to the considerable variation in how individuals respond to TSO®, it is not possible to predict an accurate timeline that applies to all individuals. However, it appears that around 80 percent of those who take TSO® do eventually respond positively, although response and remission may take longer in the case of more severe or chronic conditions.
Most people notice the first improvements between the 4th full dose of 2500 TSO® (i.e., after 8 weeks) and the 6th full dose (at 12 weeks), and typically achieve remission after dose 10 (i.e., 20 weeks after commencing the use of TSO® ). However, response times do vary, and more than 10 full doses may be required in the case of people with very severe or chronic disease.
Experience gained from the use of TSO® in thousands of individuals over more than a decade, both in and outside clinical studies, suggests that the earlier in the disease process the treatment is initiated, the more rapidly it will work and the longer remission is likely to last once it has been achieved.
People who stop treatment after remission is achieved do not usually relapse again for between 1 and 3 years, and even longer periods of remission have been reported.
A few self-treaters may need long-term treatment with TSO®, especially elderly individuals with a long history of autoimmune disease. One condition that may require long-term treatment is multiple sclerosis, and eczema is another, although this is dependent on how effectively the immune system can reset itself under the influence of the TSO®.

The safety of TSO®

The approval certificate for TSO®, issued by the Thai FDA, translates into English as follows.
“According to the request for classification and export permission of TSO as a medicine for the therapeutic treatment of inflammatory bowel diseases (Crohn`s disease and ulcerative colitis), the food and drug administration committé has discussed the therapy and all manufacturing details. The committé recognized the intended use for the curative treatment of humans and decided TSO to be a drug according to paragraph 4 of the drug law from 1967. The production method shows that TSO is derived from animals as a complete biological organism, remains unchanged and is not mixed with another drug or synthetic solution. Therefore we decided that TSO is classified under the category of natural medicines like herbals, which are exempted from the drug registration requirements according to paragraph 79 of the drug law from 1967.” (Director Drug Control, Deputy Director of the FDA Committé)
TSO® has been used experimentally in humans since scientists at Iowa University began to study it in 1995. Since then, its manufacturing process has passed all the GMP (Good Manufacturing Practice) evaluations required by the US Food and Drug Administration (FDA), the German Federal Institute for Drugs and Medical Devices (BfArm) and the appropriate medical agencies of Denmark, Switzerland, Austria and the Czech Republic. Gaining these safety approvals was a precondition for securing permission from these agencies to carry out clinical trials in humans, including phase 3 trials, which added further confirmation of the safety of TSO®.

Contraindications

TSO® should not be taken by anyone who is sensitive to the active ingredient or to any other ingredient in the product. TSO® is also contraindicated in patients who have had their small intestine partially or completely removed, and in anyone with total food intolerance or a mast cell disorder such as MCAD or MCAS, because individuals with these conditions can respond too strongly to TSO®.

Precautions and warnings

Interaction with other medications

No medications are currently known to interact with TSO® except anthelmintic drugs, which effectively cancel out the beneficial effects of the organism while the drug is being taken. TSO® can therefore be combined with all known conventional pharmaceutical preparations except those with anthelmintic effects. TSO® is also unaffected by alcohol.
For further details, please see the section, “Substances best avoided while taking TSO®“, below.

Overdose risk

No cases of overdosing with TSO have been recorded, even though three times the recommended fortnightly dose of 2500 TSO (i.e., a total of 7500) has been taken by a number of individuals, including subjects in clinical trials. One reason for the absence of any overdose effect is that the number of ova that are able to attach to the caecum and begin to grow is limited, and any ova that are unable to attach are digested and excreted in the feces.

Pregnancy and lactation

No negative influences by TSO® are known currently in the case of either mother or baby but, given the lack of appropriate clinical studies, it is advisable not to take TSO® during pregnancy unless its use is approved by a medical professional.

Children

Children under the age of 12 have different dosing requirements from adults. See below for details of age-appropriate dosing regimens.

Taking TSO®

One full 30 ml bottle containing 500, 1000 or 2500 ova in 15 ml of saline solution constitutes one dose of TSO®.

After drinking the contents of the bottle, it is recommended to partially refill the bottle with a neutral liquid, and to also drink this after gently swirling it around to gather up any TSO® that may have adhered to the inside wall of the bottle.

A dose can be taken at any time of the day.

Taking TSO® on an empty stomach does allow the eggs to move through the digestive tract a little more quickly and hatch a little earlier than if they are delayed while a meal is being digested. However, this small saving of time is the only benefit of taking TSO® between meals.

Dosing with TSO®

Adults

The basic dosing regimen consists of 10 doses of 2500 TSO®, one of which doses is taken every 14 days. This dosing approach was established in early clinical trials and has been confirmed by two decades of experience by Tanawisa in working with users of this species.
In cases of more severe or chronic disease, up to 20 doses of 2500 TSO® may be necessary. Alternatively, if a full course of 10 fortnightly doses of 2500 TSO® has not resulted in complete disease remission but has been well tolerated, it is safe to increase the dosage, first to 5000 TSO® every two weeks, and, if necessary, even to 7500 TSO® fortnightly. While these higher doses have brought success in most cases where doses of 2500 TSO® had failed to achieve remission, it is always best to start with 10 doses of 2500 TSO® and only escalate the dosage after 10 weeks if this is found to be necessary.
Some people have noticed that they begin to experience a return of disease symptoms slightly before the next dose is due. In these cases, shortening the period between doses by one or two days will prevent the reappearance of symptoms.

TSO® can safely be taken long term, if required.

The elderly and those with long-term illness

One dose of 2500 TSO® every 14 days.

Adults with only moderate symptoms

One dose of 1000 TSO® every 14 days.

Young people (8 years and over) with moderate symptoms

One dose of 500 TSO® every 14 days.

Children aged 3 and over

TSO® should only be administered to children under a physician’s supervision.
A graduated protocol should be employed, commencing with one very small dose taken every 2 weeks, and with the number of ova in each dose gradually being increased over a 10 week period. This entire protocol will require a total of 5 bottles of 500 TSO® and 3 bottles of 1000 TSO®, all of which should be stored in a refrigerator, and not a freezer.

The doses should be measured using a 5ml medicine syringe, or pipette, purchased from any drugstore.
Dose 1. Take a bottle of 500 TSO®, shake this well, and then draw up 3ml of the solution using the pipette, add the liquid to a spoon or mix it with any drink, and administer.
Dose 2. After 2 weeks, repeat as described for dose 1, but draw up 6ml.
Dose 3. After another 2 weeks, draw up 9ml.
Dose 4. After another 2 weeks, draw up 12 ml.
Dose 5. After another 2 weeks, give one full dose of 500 TSO®.
Dose 6. After another 2 weeks, give one full dose of 500 TSO®.
Dose 7. After another 2 weeks, give one full dose of 500 TSO®.
Dose 8. After another 2 weeks, give one full dose of 1000 TSO®.
Dose 9. After another 2 weeks, give one full dose of 1000 TSO®.
Dose 10. After another 2 weeks, give one full dose of 1000 TSO®.
After a further 2 weeks, report progress to Tanawisa, who will provide advice on how to proceed.
It is often unnecessary to continue treatment following this adaptation regimen, but, if further treatment is required, most children will be able to jump to doses of 2500 TSO® at this point.

Children under 3 years old

A physician should be involved in decisions about dosing for children In this group.

Conditions that require a modified approach to dosing

• chronic fatigue syndrome (CFS)
• depression, especially if severe
• eosinophilic esophagitis / oesophagitis (EoE)
• eosinophilic gastroenteritis (EG)
• fibromyalgia
• helminth permissive immunity, as a result of genetic factors enabling the prolonged persistence of helminths
• lung disease, especially if associated with scleroderma
• myalgic encephalomyelitis (ME)
• multiple chemical sensitivity (MCS)
• multiple food intolerance
• mitochondrial dysfunction
• narcolepsy

If one or more of the above mentioned conditions is present before starting with TSO®, different effects may or may not occur. These effects are not caused directly by the TSO®, but are a result of the process of realignment of immune function which is triggered by the TSO®.

People with these conditions should start with the lowest possible dose size, and a further dose should only be added after all effects from the previous dose have subsided. The size of subsequent doses can then be increased very gradually, bearing in mind the possibility that the size of doses may need to be limited indefinitely.
These recommendations are even more important for females with any of the conditions listed above, since they appear to experience a somewhat increased severity of side effects in comparison with males.

Dividing doses

Small doses of TSO® can be created easily by dividing the contents of a bottle containing a larger dose. For example, after first shaking the bottle to evenly distribute the organisms it contains, doses of 500 TSO® can be created from a bottle of 1000 TSO® by carefully pouring out half of its contents. But, if using a bottle of 2500 ova to create five doses of 500, it’s best not to attempt to pour out a fifth of the liquid by sight. Instead, after shaking the bottle, use a medicine syringe or pipette to immediately draw up 3 ml of the liquid for each dose of 500 TSO®. Similarly, doses of 250 can be created from a bottle of 2500 TSO® by shaking the bottle and then immediately drawing off 1.5 ml. The bottle, containing any remaining ova, should be stored in a refrigerator until next required.

Pausing treatment with TSO®

Treatment with TSO® can be paused at any time, if necessary. For example, if an anthelmintic drug such as albendazole or mebendazole needs to be taken to treat a pathogenic parasitic infection.

Special applications

Small doses of TSO® can be used for a number of additional purposes, including:
* to complement therapy with a different helminth species,
* to help modulate the severity of the skin response to inoculation with Necator americanus (NA),
* as a temporary replacement for a different helminth, if access to that species is limited.

Possible effects when TSO® is first introduced

The initial introduction of TSO® can be followed by a short period of mild diarrhea accompanied by pungent flatulence and a little stomach grumbling. This occurs as a result of the intestinal flora changing rapidly and radically under the action of the TSO®, from a dominance by pathogenic bacteria to dominance by beneficial ones.

When this effect does occur, it is usually only experienced after the first dose, or, more rarely, after the first few doses, and it gradually decreases in severity with each successive dose. Occasionally, there may be mild effects that only appear after the third or fourth dose, and, in rare cases, these may be more persistent. The following two symptoms are examples of this possibility.

Allergies

While TSO® have been found to help treat contact allergies, they can occasionally exacerbate other forms of allergy.

Reflux / heartburn / nausea / gastritis

These symptoms can appear in individuals with a prior tendency to reflux/GERD, or to gastroparesis.

Sensitivity to low pH

Some people can be sensitive to the low pH of the phosphate-buffered saline solution in which the TSO® are suspended. This is pH 2.4, which is similar to the pH of Coca Cola. However, any skin response caused by this sensitivity should resolve quickly, and can be prevented by mixing the TSO® with Gatorade, which dilutes the fluid and raises the pH.

Avoiding unwanted effects: the adaptation regimen

Anyone who is concerned about the possibility of the effects described above can start with a lower fortnightly dose and build up gradually to doses of 2500. For example, as follows:
* Two doses of 500 TSO®, followed by
* two doses of 1000 TSO®, and then
* six doses of 2500 TSO®.
If someone who starts with doses of 2500 feels uncomfortable with a transient appearance of diarrhea or other effects, they should switch to this adaptation regimen. If unwanted effects are experienced at any stage of the adaptation regimen, that stage should be continued until the effects have completely resolved. However, while this regimen can make the treatment more comfortable, it also inevitably extends the time that it will take to see the first noticeable improvements.
If a patient is being cared for by a helminthic therapy-aware doctor, the latter may prescribe a short course of prednisone with a suitable taper as an alternative to the adaptation regimen. This drug treatment will usually allow the patient to take full doses of 2500 TSO® without experiencing any unwanted effects.

Storage and survival of TSO®

TSO® has two kinds of shelf life. Firstly, there is the biological shelf life which is the time that the ova remain viable, and, secondly, there is the microbiological shelf life of the fluid in which the TSO® organisms are suspended.

In their natural life cycle, the eggs are shed by their porcine (pig) hosts into the soil, where they can remain viable for up to 9 years while exposed to all kind of weather conditions from very hot to very cold. When the next pig picks them up, they attach to its intestinal mucosa, hatch and start their development.

The microbiological shelf life refers to the bacterial load of the fluid inside the vials until they exceed the limits according to the pharmacopeia for fluid medicines, which is at least 1 year depending on the conditions in which the vials are stored. If they are stored inside a normal refrigerator, this time can be a lot longer. However, the microbiological standards according to the pharmacopeia for fluid medicines are quite high. For example if you touch your lips with your finger you are picking up about 100 times more bacteria than this limit allows. Licking on a soft ice cream would deliver approximately 1000 times more.
Each vial of TSO® shows the microbiological shelf life on its label. After receipt, TSO® should ideally be stored in a refrigerator, and this is especially important once a bottle has been opened, since the lower temperature will inhibit bacterial growth.
When stored in a refrigerator, TSO® doses can remain viable for a couple of years, making it possible to take advantage of cheaper multiple packs, and to keep doses in reserve.

Where do TS live in their host?

In humans, TSO® have been observed to settle predominantly in the caecum and the ascending and transverse sections of the colon, as shown by capital letters in the following representation of the alimentary tract.
mouth ➤ oesophagus ➤ stomach ➤ duodenum ➤ jejunum ➤ ileum ➤ CAECUM ➤ ASCENDING COLON ➤ TRANSVERSE COLON ➤ Descending colon ➤ rectum
Given that TSO® eventually settle in the caecum and colon, it might be assumed that administration of TSO® via enema may be a viable alternative to the oral route, but it isn’t. The eggs need to experience the biochemical signal provided by the sudden increase in pH from the stomach (pH1) to the gut (pH8), which triggers hatching.

The question of possible TS persistence

Doctors carrying out routine colonoscopy examinations on patients who are taking TSO® have not reported finding any mature Trichuris suis, and none have been observed in any of the clinical trials that have used this species, even though these included hundreds of patients. To read these studies, search our “Research” page.

Substances best avoided while taking TSO®

Very few things will harm TSO®, with the exception of anthelmintic drugs and a few herbs and other food substances that also have anthelmintic properties.

Pharmaceutical Class

Some anthelmintic drugs may only have a mild or moderately adverse effect on TSO®, including the drugs that are used specifically to target certain other helminth species. However, there is a potential for any anthelmintic substance to at least reduce the therapeutic benefits of TSO®. The following drugs are therefore best avoided if possible.

Alcopar – (bephenium hydroxynaphthoate) anthelmintic
Anecoline – found in betel nut and used intravenously for Alzheimer’s
Metronidazole – (Flagyl, and others) is suspected to inhibit helminth effects
Albendazole – effective against threadworms, roundworms, whipworms, tapeworms and hookworms
Diethylcarbamazine – effective against Wuchereria bancrofti, Brugia malayi, Brugia timori, tropical pulmonary eosinophilia and loiasis
Mebendazole – effective against pinworms, roundworms, trichuris and hookworms
Niclosamide – effective against tapeworms
Ivermectin – effective against most common intestinal worms

Suramin - used to treat sleeping sickness and river blindness

Thiabendazole – effective against hookworms and other roundworms
Pyrantel pamoate – effective against most nematode infections
Paraherquamide – new anti-nematodal
Levamisole – very effective against hookworms
Piperazine and related derivatives – Levitra and Trazodone etc.
Praziquantel – effective against nematodes and some trematodes
Promethazine – anti-emetic
Triclabendazole – effective against liver flukes
Octadepsipeptides, e.g: Emodepside – effective against a variety of helminths
Amino Acetonitrile derivatives, e.g: Monepantel – effective against a variety of helminths, including those resistant to the other drug classes

Natural Class

Azadirachta indica (Neem) oil
Bitter mellon – a noted Asian anthelmintic.
Chenopodium ambrosioides – American wormseed
Moringa Oleifera – (Moringaceae) (Micronutrient Powder)
Black walnut (Juglans nigra)
Wormwood (Artemisia absynthium)
Clove (Syzygium aromaticum)
Tansy tea (Tanacetum vulgare)
Hagenia (Hagenia abyssinica)
Inula helenium (Elecampane) also called Horse-heal and found in absinthe
Kalonji (Nigella sativa) seeds
Male fern (Dryopteris filix-mas)
Monarda – Bee balm
Plumeria (P. acutifolia or P. rubra) used in Brazilian folk medicine.
Peganum harmala – used as an anthelmintic.
Pumpkin seeds and pumpkin seed oil – a traditional remedy for worms
Ruta graveolens – Herb-of-Grace (Common Rue)
Spondias mombin – java fruit