The quality criteria for medically relevant pro- and synbiotics
The following quality criteria were taken from the guidelines of the World Health Organisation (WHO), the US Food and Drug Administration (FDA), the World Gastroenterology Organisation and the Austrian/German Societies for Probiotic Medicine (OePROM / DePROM).
1. Number of bacteria
At least 109 KBE (= 1 billion bacteria per gramme of powder). This means that a relevant number of viable bacteria can be ingested.
2. Multi-species formula of symbiotic strains of bacteria
The combination of different strains of bacteria enables an improved synthesis between bacteria and human cells as well as a multiplication of the potential of the individual strains: a team with a range of skills is better than one lone fighter.
Probiotic bacteria are most effective in the 24 hours after they have been rehydrated, when they become active again. In yoghurt this process takes place in the dairy, where the yoghurt is created by producing lactic acid from milk, whereas in powder granulates it occurs in our bodies, where the bacteria actively do their work for us.
4. Reproductive rate
Proven reproduction of probiotic bacteria also after the end of therapy. Evidence of this has only been obtained for very few products until now, as only very high reproduction figures can be recorded. Evidence of this kind for OMNi-BiOTiC® PANDA and OMNi-BiOTiC® 10 AAD has also been published in scientific journals.
5. Stability at room temperature
The number of bacteria at the end of the best before date should be given, not the number of bacteria at the time of packaging. This is because many bacteria already die after a few days if the environment does not offer ideal conditions for their survival. Upon request, a quality analysis of every batch of OMNi-BiOTiC® products can be provided including evidence of stability at room temperature for 24 months.
6. Resistance to stomach and bile acid
The resistance of the bacteria to strong acids is an essential aspect. The revitalisation of the freeze-dried bacteria should ideally take place outside the body in a neutral liquid. There, the bacteria can ingest their first food and gain strength before they have to embark on a passage lasting hours through the stomach with its acid and through the duodenum with bile acid and pancreatic juice.
7. Optimisation of the milieu
The ideal pH value in the small intestine is 4.0-5.0. Beneficial bacteria reproduce optimally at this value, whereas pathogens do not.
8. Fast rehydration
Bacteria are instable during their ‘reawakening phase’. They only start to become active when they have received food and have become accustomed to their environment. In capsules, this process is delayed considerably.
9. Synergy of different strains of bacteria
Not all strains of bacteria harmonise with each other – on the contrary, they can become competitors (e.g. for food). The efficiency of combined bacteria products therefore needs to be proven by a so-called cross streak method, and/or there should be studies available on their effectiveness.
All of the strains of bacteria used should have obtained international GRAS (Generally recognised as safe) status, which ensures the highest level of safety for ingestion by humans and the absence of side effects, also when taken over a longer period.
11. Free of sugar, gluten and animal proteins
To avoid promoting existing intolerances.
In order to increase the activity and reproductive rate of bacteria, enzymes, fibre and minerals are added. This increases the mucus production of the intestinal lining and the adhesion of the bacteria combination which has been ingested.
OMNi-BiOTiC® products comply with these quality criteria and consist solely of bacteria cultures which are found in humans and are capable of reproduction.