How it Started
At Leucine Rich Bio, when we started working on the microbiome, probiotic supplements were not the first thing in our minds. We wanted to create a microbiome profiling tool that helps us understand what is happening in the gut. This was the thought behind BugSpeaks. With this testing kit we analysed thousands of Indian gut samples. With all this data we were beginning to get insights on which probiotics were low in the Indian population. This was on the data side. We still were not thinking of developing a supplement. Atleast not until over 95% of our clients wanted us to wok on a supplement. Secondly what we realised over time was to re-balancing of the gut, supplements were essential. Nutrition and food habits bring about sustained changes but supplements were needed to kick start the process. Thus began our journey on developing probiotic supplement.
The Process of Creation
Healthy Data
The first thing we did was to compile the data that came from healthy individuals. This was across adult age groups. Initially we had to rely on the questionnaire that were filled out to categorize and filter out healthy individuals. Later on we validated this exercise with individuals from our study where we categorized healthy based on blood biomarkers. The healthy data helped us create a baseline of the probiotics. As it was an exercise that was undertaken for the first time in India, it took us couple years to arrive at these numbers.
Dysbiosis Cohort
The next step was to look at a diverse set of diseased individuals. Diversity in the disease background was important. This was the best way, in our opinion, to determine the unhealthy population data. Our belief is that no single disease condition is skewing the data. From there we had to define what dysbiosis was in terms of data. Our work on developing the Rych Index for BugSpeaks helped here.
The Math
With thousands of data categorized we went about finding out which probiotic was absent or low in the gut of individuals with dysbiosis. This was again not straightforward. We had to be very thorough in our analysis and get it validated by seasoned bio-statisticians.
The Combination
We narrowed down to 7 probiotics. 6 Bacteria and 1 Fungus. There were one or two species that surprised us. Lactobacillus casei, for example, we thought would be highly abundant in the Indian population. On the contrary it was one that was missing in the disease cohort. Microbiome data from western countries have shown Bifidobacterium missing and in the Indian population it was present in good numbers. Many reasons for this we shall write a blog on it soon. The combination we finally came up with came purely from the data and early anecdotal evidence suggests that the numbers did not lie.
CFU
This was by far the most challenging piece in the entire process. To come up with the right concentration of the probiotics. The first problem was the stomach acid. Probiotic supplements get destroyed by the stomach acids. One way to overcome this is by putting the supplements in a acid resistant capsule. This then puts us in the mercy of capsule manufacturers and their claims. Going with a manufacturer with good scientific data but with moderate acid resistant potential versus a manufacturer with tall claims but no scientific data made more sense. The second problem was determining the actual CFU that was needed. This was not easy. Here we relied on multi-strain probiotic clinical trial data. We investigated what worked and what did not work. After extensive data analysis we arrived at 50 Billion CFU.
Prebiotics
The decision to add a prebiotic was tricky one and our team was evenly divided on this. What convinced us was again the clinical trial data and what worked in those trials. Hence we chose to add Fructo-oligosaccharides(FOS). We got the concentration wrong in our trial batch. We added 500mg of FOS and that resulted in bloating. We had to reduce it down to 50mg. This worked and if any user gets mild bloating initially, its because of the FOS. The bloating will generally subside within 2-3 days.
Capsule Size
Size 0 was the default and only choice. When it comes to capsules the bigger the number the smaller the size of the capsule. We tried fitting the powder in Size 1 capsule and it unfortunately was too small. We had no option but to use and continue to use Size 0 capsules.
Species & Not Strains
Lactobacillus casei, Lactobacillus paracasei or Bacillus coagulans are all species. We had control over what species we need to add to our probitoic. Strains are one level lower in taxonomy and each species can have thousands of strains. It is similar to the different variants of Covid. All have more or less the same profile but there are minute differences. Unfortunately manufacturers in India and globally have access to limited strains. We had to chose from the strains they have and not from the data. This does not mean it was bad, it was good but not very good. 9 out of 10 versus 10 out of 10. This is something we are actively working on. Will write a post on this soon.
Manufacturer
We tried and tested a few good manufacturers and settled down on one in Ahmadabad. Here too our choice was a good manufacturer with rigorous scientific process. The cost was higher but the quality was good.
Indus
We named it RychBiome Indus because it was based on the Indian microbiome data. Made in India using Indian data for Indians.
That is the origin story of RychBiome Indus.
This research also threw up a new question and in our next blog we would like to talk about that. "What is a supplement and what should it do?"