Gastric resistance and colonization of the intestinal tract

Trial 130.1: The ability of Kluyveromyces marxianus fragilis B0399 to pass through the gastric barrier and colonize the intestine - examination of human feces after oral uptake by healthy volunteers.

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.

0 – SUMMARY:

- Giorgio Mustacchi (Centro Oncologico Azienda per i Servizi sanitari N° 1 – triestina, Università degli Studi di Trieste): ): Head of the experimentation and statistic calculation.

- 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)

2 - INTRODUCTION:

Objective of the study

β

3.1 – Enrolled subjects

Criteria for exclusion

Examination of fecal samples

Initial criteria of evaluation

Collection of sample:

5 - RISULTS:

7 - CONCLUSIONS:

8 - ATTACHMENTS:

• Attachment B –Dr. Bearzi  of the  Laboratorio analisi della Casa di Cura Pineta del Carso (Aurisina- Trieste) – preparation of the samples in suspension
• Attachment C: Dr Collavini Certificate of analysis CATAS S.p.a. Laboratorio ambiente e agroalimentare (microbiiological laboratory);

BIBLIOGRAPHY:

1. Lachance M.A. (1970) Kluyveromyces: systematics since  Antoine van Leeuwenhoek 63: 95-104, 1993.
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6. Lovrovich Paola Ricerca bibliografica.: Il maiale come modello adatto alla sperimentazione applicata del sistema digerente umano. <http://www.turval.com/research/humans/>Expertise - 2008; agg.2009 
9. Directives   70/524, 87/153, 94/40 EEC EU (  regolamento 377/2006  ) ; Trial# 22, agg. 2009.
10. Andreoli  Sandro  Gastroenterologo Risultati clinici del trattamento con lievito lattico Kluyveromyces B0399 nella Sindrome dell’Intestino Irritabile” Expertise.
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