Frequently Asked Questions
The following questions and answers will help you take a closer look at the probiotic VSL#3® and how your patients should use it.
- What should VSL#3® be used for?
- Is VSL#3® a drug?
- What is a medical food?
- Do I need to prescribe VSL#3®?
- How is VSL#3® different from other probiotic product?
- How does VSL#3® work?
- Are there any studies on VSL#3®?
- How do patients take VSL#3®?
- Are there any foods that should be avoided when taking VSL#3®?
- How should VSL#3® be dosed?
- Can my patients take too much VSL#3®?
- Will insurance cover VSL#3®?
- How long does VSL#3® take to work?
- Is VSL#3® safe for children?
- Is VSL#3® compatible with antibiotics?
- Can my patients take VSL#3® if they are intolerant to dairy products?
- What happens if VSL#3® is left at room temperature?
What should VSL#3® be used for?
VSL#3® is intended to be used in the dietary management of medically diagnosed ulcerative colitis, irritable bowel syndrome, or an ileal pouch. VSL#3®:
- Decreases diarrhea, frequency, and urgency.19,35,44
- Protects the gastrointestinal tract and reduces intestinal inflammation. 22,35,39,49,64
- VSL#3® may help patients with ulcerative colitis or an ileal pouch to maintain remission and prevent relapse of active ulcerative colitis or pouchitis. 19,20,44,66
- VSL#3® probiotic proves effective in the dietary management of the most challenging IBS symptoms.2,33,68,69
Is VSL#3® a drug?
No, VSL#3® is a medical food that is intended for use under the supervision of a physician.
What is a medical food?
A medical food is a product that is intended for use in the dietary management of a medical disorder, disease or condition with distinctive nutritional requirements, under the supervision of a physician or medical professional.
Do I need to prescribe VSL#3®?
No prescription is needed. However, VSL#3® should be used under the supervision of a medical professional.
How is VSL#3® different from other probiotic probiotics?
VSL#3® is different from other probiotic products because it has the highest available concentration of beneficial bacteria (450 billion per dose). Most other probiotic preparations only have 1 to 5 billion bacteria, which is generally not sufficient to have a therapeutic effect. Also, VSL#3® is the only probiotic that has been shown to aid in the dietary management of serious intestinal disorders in several double-blind, placebo controlled, peer-reviewed studies.
How does VSL#3® work?
VSL#3® works by colonizing the gastrointestinal (GI) tract with optimal quantities and types of beneficial probiotic bacteria. Studies have shown that VSL#3®:
- Provides probiotic bacteria to help protect the gastrointestinal tract 22,35,38,49,64
- Modulates intestinal inflammation 22,35,39,49,64
- Aids in the dietary management of ulcerative colitis (UC), irritable bowel syndrome (IBS) and an ileal pouch 3,19, 20,33,44,63,66,69
Are there any studies on VSL#3®?
Yes. To date there have been over 35 clinical trials published in top medical journals supporting VSL#3®. No other probiotic product has more published data than VSL#3®.
How do patients take VSL#3®?
VSL#3® is a lemon-flavored powder that is mixed in a small amount of water and consumed.
Are there any foods that should be avoided when taking VSL#3®?
VSL#3® is generally compatible with any food you ordinarily consume.
How much VSL#3® should I recommend my patients take?
Clinical studies that have evaluated VSL#3, used varying daily amounts of product, from 450 (1 packet) to 3,600 (8 packets) billion bacteria.
Recommended Daily Intake for Adults
| RECOMMENDED DAILY INTAKE FOR ADULTS | ||
|---|---|---|
| For the dietary management of: |
Sachets* Per Day |
Capsules* Per Day |
| Irritable Bowel Syndrome | 1/2-1 | 2-4 |
| Ulcerative Colitis | 1-2 | 4-8 |
| Pouchitis | 2-4 | 6-18 |
| Active Ulcerative Colitis | 4-8 | 16-32 |
| *1 sachet = 450 bacteria. 2 capsules = 225 billion bacteria |
|---|
Can my patients take too much VSL#3®?
To date, there have been no reports of overdose with VSL#3® or other probiotic products. Available experimental and clinical studies have demonstrated no significant negative effects related to the product. This is not surprising as the strains of lactic acid bacteria used in VSL#3® are physiologically part of the endogenous microflora of the human gut. A minority of subjects consuming VSL#3® have complained of bloating, when consuming 8 packets daily.
Will insurance cover VSL#3®?
Some insurance companies will cover medical food products like VSL#3® when medically justified. VSL#3® Pharmaceuticals Inc. offers free support to your patients who are pursuing reimbursement through our Reimbursement Support Hotline at 800-490-3262.
How long does VSL#3® take to work?
In general, initial results can be expected within 1 week while the maximal effects can be expected within 2 to 3 weeks from first consumption. A study conducted with VSL#3® confirms that maximum bacterial colonization of the gut occurs 20 days after the start of VSL#3®. This high level of colonization remains stable while consuming VSL#3 on a daily basis. After stopping daily consumption, the "good" bacteria are lost in approximately 2 to 3 weeks.
Is VSL#3® safe for children?
A significant number of studies of bacteriotherapy with probiotic bacteria have been performed in children and none of them has reported any adverse events. It is reasonable to regard VSL#3® as safe for children.
Is VSL#3® compatible with antibiotics?
VSL#3® is believed to be compatible with all types of drugs with the exception of antibiotics. Taking VSL#3® with antibiotics will not harm you but the effects of VSL#3® will be reduced since the antibiotics can inactivate the microorganisms in VSL#3®.
Can my patients take VSL#3® if they are intolerant to dairy products?
Some dairy ingredients are used in the culture medium but are removed during fermentation and concentration. There might be trace amounts at very low levels and for this reason, VSL#3® is not defined as a dairy-free product but as a non-dairy product. Evidence suggests that probiotics may be useful for patients with lactose maldigestion and lactase deficiency. Recent studies have demonstrated that lactose is better digested from yogurt than from milk by lactase-deficient individuals and yogurt ingestion by these patients is paralleled by reduced symptoms. Many patients confirmed that their intolerance was greatly reduced with the use of VSL#3®. If your patient is lactose intolerant, you may wish to start them with a very low daily intake of VSL#3® to see how they respond before intake.
What happens if VSL#3® is left at room temperature?
It will be fine for about 1 week as long as it is not heated above room temperature or exposed to excessive heat. If it is left at room temperature for long periods of time or exposed to excessive heat, the microorganisms in VSL#3® can become greatly reduced.
