Frequently asked questions.
Below you can find detailed answers to questions that are related to the product and its formulation.
Irritable bowel syndrome (IBS) is a chronic functional disorder of the gastrointestinal tract characterised, to varying degrees, by the presence of chronic abdominal pain and changes in the intestinal habit in absence of an organic disease. The pathophysiology of IBS has not yet been fully clarified, but it seems to derive from the complex interaction between genetic, lifestyle, dietary and environmental factors. IBS signs and symptoms include cramping, abdominal pain, bloating, gas, diarrhea or constipation, or both.
The largest populations of microorganisms including bacteria, fungi and viruses reside in the intestine and is collectively called gut microbiota. These microorganisms play a crucial role in the homeostasis of the metabolism, the regulation of the immune system and the protection of the human organism against pathogens invasion.
Dysbiosis is a condition in the intestine that is characterised by altered gut bacterial composition. Dysbiosis has been associated with the cause of many inflammatory diseases, infections and functional disorders including IBS, a common disorder that affects the large intestine. BIOintestil® offers irritable bowel syndrome (IBS) symptoms relief through gut microbiota modulation.
Eubiotics are positive modulators of the intestinal microbiota. The term refers to several natural substances such as some essential oils which can modify positively the intestinal microbiota. The general term ‘eubiotics’, is related to the Greek term ‘eubiosis’ and refers to an optimal balance of microflora in the gastrointestinal tract. The main purpose of using eubiotics is to maintain the intestinal eubiosis.
BIOintestil® is a ground-breaking eubiotic food supplement. The product is able to improve symptoms associated with IBS, but it is not working in the same way prebiotics or probiotics work. For example, it does not remain in the gastrointestinal tract to colonise it, so it cannot be considered a probiotic, nor it helps other microorganisms to grow, so it cannot be considered a prebiotic.
It is not an antibiotic (the product is not able to kill generally all the microorganisms, nor pathogens like Salmonella); it only acts selectively on ‘possibly’ pathogenic bacteria, so called “opportunistic pathogens”. These opportunistic pathogens are bacteria, commonly present in the gut, that can cause diseases when growing above a certain level. Thus, a eubiotic helps maintain the right levels of these opportunistic pathogens without affecting commensal bacteria and can contribute into making the environment favourable to re-equilibrate the microbioma, thanks to its anti-inflammatory activity and acting on COX-2 cyclooxygenase enzyme.
Geraniol is a molecule naturally present in various essential oils – lemongrass, geranium, rose, lavender – but is particularly abundant in the palmarosa essential oil. Pre-clinical and clinical studies demonstrate that geraniol has significant antimicrobial, antioxidant and anti-inflammatory properties.
Gingerol exhibits antioxidant, anti-inflammatory as well as antiemetic properties.
In the innovative BIOintestil® formulation, the use of ginger rhizome powder in the mix allows geraniol to remain absorbed in the fiber and pass intact through the first tract of the intestine. Thanks to this, geraniol is released topically in the colon in a high percentage, supporting a natural rebalance of the gut microbial community.
Based on preclinical scientific studies and a pilot clinical trial on patients with IBS which was conducted at the Department of Clinical Medicine of the S. Orsola Hospital, University of Bologna and the Department of Clinical and Experimental Sciences at the Spedali Civili Hospital in Brescia (a teaching hospital in Lombardy with over 1500 beds), BIOintestil® has been shown to be able to positively modulate the intestinal microbiota, reduce abdominal swelling and regularise the intestine. The data have been further confirmed in a double-blind placebo-controlled trial conducted in the same hospitals.
The recommended dose is 3 gastroresistant capsules per day, to be taken preferably in three daily administrations before meals, with the help of a glass of water.
Geraniol is a non-toxic compound, classified as GRAS (Generally Recognised As Safe) by the FDA and has a DNEL (Derived no-effect level) of 13,5 mg/kg according to the European Food Satefy Authority (EFSA). There is a wide European regulatory framework covering the product’s ingredients safe use:
According to Ministerial Decree 27/03/2014, the essential oil of Cymbopogon martinii use is approved in food supplements for digestive function.
According to Ministerial Decree 27/03/2014, Zingiber officinale use is approved in food supplements for digestive function, regulation of gastrointestinal motility and gas elimination. Cymbopogon Martinii essential oil and Zingiber officinale rhizome powder are certified for food use.
According to 15/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, BIOintestil® does not meet the definition of a “Novel Food”.
According to Regulation (EC) 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on food, BIOintestil® can be defined as “source of fibers”.
BIOintestil® is composed 100% by mixed ingredients and meets the definition of “naturally occurring substances” according to Regulation (EC) 1907/2006.
The BIOintestil® basic ingredients – palmarosa and ginger – do not naturally contain gluten. However, the production chain is not certified as gluten-free. BIOintestil® may have traces of gluten due to its production process.
Yes, the product is GMO-free. It does not contain, does not derive and is not made up of Genetically Modified Organisms. BIOintestil® is in agreement with Regulations EC 1829/2003 and 1830/2003. Notably:
- Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed and
- Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.
Nο, the product cannot be considered vegan. Despite the fact that the basic ingredients – palmarosa and ginger – used in BIOintestil® are vegan per se, the production process is not certified as vegan.
The BIOintestil® product formulation and its production technology are patented (EU patent application n°16171535.4-1466). The patent covers:
- The use of essential oils or their individual components absorbed on vegetable fiber in order to release the active substances of BIOintestil® in the colon.
- The mixing process that optimises the powder, making it easier to be manipulated and encapsulated.
The BIOintestil® raw materials come from China/India (ginger) and Brazil (palmarosa), their native environments, while their processing is done in Italy – for example ginger is dried and pulverized in Italy.
The raw materials’ quality is double-checked:
- Ginger and palmarosa arrive in Italy with their own certifications of analysis. Distributors check these certifications while conducting their quality assurance and quality control procedures.
- Raw materials are also checked in the final product. Manufacturers conduct several tests on the final product ingredients’ compostition, including for example testing for pesticides, mycotoxins, allergens, salmonella, E. coli and much more.
Targeting Gut Disease (TGD) has developed BIOintestil® as a raw material to be used alone or in combination with other ingredients in food supplements. As a raw material, the product is sold in the form of hygroscopic powder.
BIOintestil® is also available as a ready-made food supplement, BIOintestil® Complex, to be used directly from consumers, in the form of capsules (capsules containing 400mg of BIOintestil®).
The nutritional information for three BIOintestil® Complex capsules is:
- BIOintestil® 1.2 g
- Ginger 960.0 mg of which fiber 138.2 mg and
- Palmarosa essential oil: 240.0 mg
1 The fresh ginger is dried and turned into powder in Italy.
2 The palmarosa essential oil with a very high content of geraniol is added to the mix and absorbed in the powder in Italy.
3 The final product (raw material) is formulated.
4 In the ready-made food supplement (BIOintestil® Complex), excipients are added to the mixture to facilitate the encapsulation.