What Does ‘Scientifically Proven’ Really Mean?
A Guide to Scientific Probiotic Testing and How To Tell What’s Really Been Researched
We all like to see those words on our supplement labels ‘scientifically proven’. It brings to mind images of a lab full of scientists in white coats proving the effectiveness of the contents of this little bottle. It creates a feeling that what we’re taking isn’t based upon ‘it might help you’ but that it’s based upon ‘science has proven it will help you’. It fills us with confidence that the evidence is strong and trustworthy.
But the question is, how does the testing work? Is it all the same? What are the standards? And how are you supposed to know what’s been tested properly and what hasn’t? How do you know it isn’t just marketing?
In this blog we’re going to break it down for you in plain English, not scientific jargon. We’ll go through the 3 main types of testing that are used not just for probiotics, but for medicines in pharmaceutical drugs too, so you know that when you see ‘scientifically proven probiotics’ on a label you’ll be able to tell if it’s true or just marketing!
So, let’s go on a little journey to see what scientifically proven probiotics really means.
Preclinical Testing – It’s a start…but is it enough?
A lot of probiotic supplements on the market today are backed by preclinical research, and some by only preclinical research. For a bacterium that has not really been studied much, or medical drugs for that matter, this is often the starting point, since it’s the cheapest type of research to do and it gives us some early ideas of what we’re dealing with. Let’s look at why.
Preclinical testing typically involves two different areas: testing in a lab in test tubes, petri dishes and so on, and testing in animals. Let’s start with the test tubes.
Before they go diving into testing products on hundreds of people, the researchers might ask questions like ‘can this bacterium survive stomach acid?’ or ‘how will it interact with digestive enzymes?’. To find out, they create an acidic solution that closely resembles the PH of a stomach, and then put some of the bacteria in it to see what happens. Let’s say the bacteria survive, this means they can say the bacteria might survive the stomach.
But, notice the word ‘might’. That’s because the human digestive system is a complex thing, and just because it doesn’t die in acid doesn’t mean something else in there won’t kill it or alter it somehow, so while this result suggests the bacteria survive the stomach, we don’t actually know because it wasn’t tested in a real stomach. The only thing we can say is that there’s a chance.
This type of testing covers a lot of other areas as well, combining the bacteria with a variety of different cells, digestive fluids, enzymes and all sorts of other things derived from a human to see what happens and how they interact.
The other area of preclinical testing is testing in animals. This is common not only in supplements but widely used in the pharmaceutical industry as well. Here scientists will give the medicine or bacteria to an animal to see what happens. Sometimes they hope to affect an illness the animal has, sometimes they’re just monitoring to see how the animal’s body responds, sometimes they want to monitor changes in behaviour or any other changes that might present themselves.
Again, this evidence can give us an idea of how it might work in humans, but a person isn’t a rat, so it’s not conclusive evidence.
Because these tests don’t involve using real people, they typically don’t cost quite as much. There are a lot of bacteria on the market that only have preclinical testing behind them and nothing else, so it’s important to check the science and know your bacteria! The good thing about this type of test is that it gives us some early ideas of how the bacteria could behave, and reassures us that the chances of any problems arising are unlikely, important if we’re going to test it in real people!
Open Label and Observational – The Start of Human Testing
The next step up from the preclinical world is to get some real humans involved, and these take the form of the open label and observational trials. These studies are conducted in real humans, but, they do have some shortcomings that mean they’re still not the solid evidence we need, but they’re a great start. Let’s take a look.
Open Label
These are trials where they literally take a group of people and give them all the bacteria or the pharmaceutical. They’re often short trials, sometimes only lasting a couple of weeks, and the goal in them is typically to see how the people react. What do their bodies do? Can they tolerate the dose or was it a bit too much? What about allergies? Were there any serious problems straight off the bat? These trials have no placebo group, so there’s nobody to compare the people who took the bacteria too. The upshot is that these studies are not really done to prove any effects or benefits, but more to test safety and tolerability before going ahead to conduct bigger trials.
Observational Studies
These studies basically involve a similar approach with a few small differences. The researchers will typically give a group of people the bacteria or drug and then monitor them for a while to see what happens. Or maybe they’ll just take a ‘snapshot’ in a few weeks to see what they find and try and find a pattern in the results. The good thing about this method is that it can give us an idea of things that might happen, but we can’t say for certain what actually caused it. People live their lives, and if we follow them for a few weeks we can’t say for certain that changes they experienced were because of bacteria or the drugs they were given. What else were they eating or drinking? What else were they exposed to? These things have an effect.
In other words, the uncontrolled human trials are a great starting point. They’re cheaper than the next step up, they establish that the bacteria or medicine is safe with no immediate side effects, and they give us an idea of what it might do and how it might benefit the user. That last point is especially important as a lot of the higher quality clinical trials will be based on the results of what they found in the observational study. So if all these results show the green light, it’s time to step up to the next level of clinical testing…
Randomised Control Trials – The Gold Standard
Randomised control trials are the big one. These are the types of clinical research that pharmaceutical medications have to be proven by before they can be approved for use in the general public, and for good reason. There are a couple of minor variations, but they ensure that the standards are high and the results are reliable, so we know that this isn’t circumstantial evidence, it’s real.
All randomised control trials (or RCTs for short) use a ‘placebo’ group. This is a group of people who don’t get the drug or the bacteria at all, instead they get a placebo that looks the same, tastes the same, smells the same, but has no effect whatsoever, so as far as they know they’ve taken the real thing. This means that when we look at the differences between the two groups, we know for a fact that the differences are because of what we gave them, and not because they expected to have a benefit since they don’t know what they took.
The really high quality RCTs are ‘double blind’, these are the tippy top of testing standards. In these studies even the researchers don’t know who got what, bacteria or placebo, until the results are in and the differences observed. This way there can be no bias at all. Even if the researchers want to find a certain result and prove a certain effect (and given that a lot of medical research is funded by pharmaceutical companies, that’s not such a stretch) they can’t throw the test off and there can be no accusations of bias because they don’t know who got the medicine and who got the placebo, and they have no way of knowing until the results are in.
This research is often conducted in stages that take the form of multiple studies. First they do the ‘pilot’ study, this is with a small group of people, to see if they get the results they hope for and to make sure the results are strong. Then they do more studies, each time with more people than the last, so they can make sure that any positive results were not just a fluke, but were consistent even across bigger groups of people.
Double blind RCTs are considered the gold standard, and any medicine or bacteria that is backed by them is taken very seriously in the medical and scientific world.
Meta Analyses – an honourable mention
Meta analyses are extremely helpful when it comes to drugs or bacteria that have a lot of research behind them. When you have 100 clinical trials, and they’re all RCTs so you know they’re serious and of a high standard, how are you supposed to compare them all? It’s a lot to go through!
That’s where meta-analyses step in. They take a handful of studies, sometimes 5, sometimes more, and all conducted to the same standard and on roughly the same subject looking at the same outcomes, and add all the results together to see what the overall pattern looks like. In other words, it steps back to look at the big picture once we put all the research together.
This is late stage research, and really helps to reinforce what has to already be a very solid body of evidence, as there has to be a good number of high quality studies available to analyse, so if there are meta-analyses that use high quality RCT trials you know you’re dealing with a bacteria that has solid scientific research behind it.
So What Does This Mean For Me?
It’s very rare that any probiotic company will detail the research behind their bacteria on the label of the bottle, it’s just too much writing for such a small space! As a result a lot of people don’t know how their product has been tested before buying it!
But if you go to their websites, a lot of the time there’ll be some detail at least to tell you what you’re taking, and if there isn’t, then try searching for name of the bacterium (don’t forget the strain ID!) to see what it turns up. Here you can find out if the research that ‘scientifically proves’ the bacteria was high quality, human research, or if it was just preclinical.
At BetterGuts we use two of the most researched bacteria in the world, Bifidobacterium Animalis BB12 and L.Rhamnosus GG. Both of these bacteria have hundreds of human trials behind them. Many of these trials were RCTs, so we know that the standards were high, and of those RCTs many were double blind. This means that these bacteria have not only a very large body of scientific study behind them, but that it’s study of the same quality that governments require for medical drugs. It’s the highest standard, and that’s why we chose these bacteria for our products.
We’re incredibly proud of the scientific backing of the bacteria we use. If you’re interested in learning more about the evidence behind our bacteria, and diving into what the research shows and what we know, check out our other articles in the Learn Hub! At BetterGuts, we love the science, and as part of our commitment to transparency we’ll always make it available.
