This study proposed to evaluate the colonization of the gastrointestinal tract after the utilization of Il Kluyveromyces marxianus fragilis B0399. It is clearly demonstrates its ability of resistance to the gastric barrier and suggests that it can be effectively taken even at much lower dosages than those examined. Also noteworthy, since it is a probiotic composed of yeasts, Kluyveromyces fragilis marxianus B0399 could be taken together with antibiotics.
Giorgio Mustacchi (Oncological Centre, Local Health N1-Trieste; Trieste University) ; Antonio Miclavez ; Alessandro Turello;
Franca Bearzi;Flaviano Collavini; Paolo Valles.
This study proposed to evaluate the colonization of the gastrointestinal tract after the utilization of Il Kluyveromyces marxianus fragilis B0399. The product was administered to 17 healthy volunteers for a period of 14 day.The intake of Kluyveromyces fragilis marxianus B0399 B0399 on the part of the healthy subjects at the dosage of 20 million CFU/diem for 2 weeks proves to be more than sufficient for intestinal colonization to take place without any side effects.
It is clearly demonstrates its ability of resistance to the gastric barrier and suggests that it can be effectively taken even at much lower dosages than those examined.
Also noteworthy, since it is a probiotic composed of yeasts, Kluyveromyces fragilis marxianus B0399 could be taken together with antibiotics.
SUMMARY
Kluyveromyces marxianus fragilis B0399 is a probiotic yeast used as a dietary supplement. This study proposed to evaluate the colonization of the gastrointestinal tract after the utilization of Il Kluyveromyces marxianus fragilis B0399.
The product was administered to 17 healthy volunteers for a period of 14 day. The feces of the subjects were analyzed to evaluate the presence of Kluyveromyces marxianus fragilis B0399at T0 (time zero), before the administration of the product (absence verification) and then at the end, after 14 days (T14 – tempo 14.)
The intake of Kluyveromyces fragilis marxianus B0399 on the part of the healthy subjects at the dosage of 20 million CFU/diem for 2 weeks proves to be more than sufficient for intestinal colonization to take place without any side effects.
The elevated magnitude of the colonization found clearly demonstrates its ability of resistance to the gastric barrier and suggests that Kluyveromyces fragilis marxianus B0399 can be effectively taken even at much lower dosages than those examined (for example: 5–10 million CFU/diem).
After examining various official trials in the animal field, it becomes questionable or even inopportune to excessively increase the daily dosage.
Also noteworthy, since it is a probiotic composed of yeasts, Kluyveromyces fragilis marxianus B0399 could be taken together with antibiotics. These characteristics, together with the absence of side effects, demonstrate a profile not only of effectiveness but of convenience and safety in usage, worthy of further scientific investigation.
1 – Researchers and facilities involved in the experimentation
Giorgio Mustacchi (Centro Oncologico Azienda per i Servizi sanitari N° 1 – triestina, Università degli Studi di Trieste): ): Head of the experimentation and statistic calculation.
Antonio Miclavez, CSM s.r.l Trieste, promoter of the study
- Alessandro Turello, Laboratori Turval s.r.l. : owner of the active ingredient (attachments A1,A2)
- Franca Bearzi, Laboratorio analisi della Casa di Cura Pineta del Carso (Aurisina- Trieste), preparation of the sample in suspension. (attachment B)
- Flaviano Collavini, CATAS S.p.a, Laboratorio ambiente e agroalimentare (laboratorio microbiologico), CCIAA di Udine ( Allegato C)
- Paolo Valles, microbiologist, Analysis at the microscope (Allegato D)
INTRODUCTION:
The intestinal bacterial flora has a key role in both nutrition and health maintenance and, in its complexity and function, plays a unique role in our organism. Several thousand different bacterial species are present in the human intestine, some considered beneficial (ex. bifidobacteria, lactobacilli, lactic yeasts) and others benign (ex. Methanogens and sucrose species of Clostridum and Bacterium) capable of contrasting the excessive multiplication of species dangerous to human health (proteolytic species of Bacteroium, Clostridium difficile, C perfrigens and the pathogen species of Enterobacteria).
Probiotics are microorganisms with the ability to bypass the gastric barrier and favor the modulation of the intestinal bacterial flora capable of surviving and maintaining viability for long periods of conservation and be harmless for man.
By introducing foods with the addition of probiotics, the useful bacteria can survive the journey through the gastroenteric tract and reach the colon. They colonize it, altering favorably the microbial equilibrium.
Probiotics have shown to be useful in the treatment of a number of intestinal problems, such as childhood diarrhea, traveler’s diarrhea and certain chronic inflammatory diseases of the intestine.
Objective of the study
The object of this study was to verify and evaluate the ability of Kluyveromyces marxianus fragilis B0399 to bypass the gastric barrier and to colonize in the intestinal tract when administered at the normal dosages suggested by the distributing company.
Some notes on the active ingredient utilized in the trial.
Kluyveromyces marxianus fragilis B0399 is a lactic yeast with characteristics which are different from those of lactobacilli and of bifidobacteria, and of the yeast Saccharomyces. It has been used for some time now as a probiotic in the zootechnical field as well (Commission Regulation EC 773/06). It is a eucaryotic type of cell (Lachance M.A 1) endowed with an elevated lactasic enzymatic activity (β-galactosidase). It ferments lactose with the production of lactic acid. The enzymatic activity, in anaerobic conditions typical of the intestine, is of a homofermenting type, in that it transforms all the resulting glucose is lactic acid, without the production of gas (C02) (ex.Saccharomyces) (Vananuvat-Kinsella2 ,Wasserman-Hopkins-Porges3). This contributes in modulation the intestinal environment, rducing the pH. Furthermore, it has shown to be particularly resistant to the action of antibiotics (Voughan 4 ).
Kluyveromyces marxianus fragilis B0399 appears to be capable of resisting gastric shock. This ability was also tested in vitro (Susmel and Stefanon5 ) by measuring the fermenting capacity before and after gastrointestinal digestion. The resistance to digestion proved to be elevated.
The ability of bypassing the gastric barrier was confirmed also by trials in vivo on monogastric animals like piglets, whose digestive apparatus is very similar to the human apparatus (Lovrovich P. 6 ) and on horses, by testing the presence of Kluyveromyces B0399 in the feces and the modification of the pH in the colon ( Lowell R. S. 7. Susmel-Stefanon 8,Bosi P. 9.)
The beneficial aspects of Kluyveromyces B0399 have also been indicated by the various studies regarding problems of the colon as well (Andreoli S.10, Irvine EJ 11, Bottona-Parisi-Zilli 12).
MATERIALS AND METHODS
As stated by the producing company (Turval Laboratories srl of Udine) the strain utilized is Kluyveromyces fragiilis marxianus B0399, deposited in BCCM-Belgium Coordinated Collections of Microorganisms, Culture Collection Mycoteque de l’Université Catholique de Lovain (Belgium) with the mark B0399, (Attachmentsi A, A2).
The experimentation