Confirmed interest for the 8 strains / 450 billion probiotic blend in ulcerative colitis and its infectious complications

The updated recommendations at the 4th Triennial Yale/Harvard Workshop on Probiotic Use held in New Haven (USA) in March 2015 confirm the effectiveness of this probiotic blend.

The JFHOD 2016 is the right occasion to get an update on the studies and recommendations on this probiotic mixture that I invented many years ago and which has been the subject of 170 scientific publications. It is still mentioned today as beneficial supplementation in the management of ulcerative colitis and its infectious complications.

Since early 2000, numerous medical publications have documented its efficacy, with high levels of evidence resulting from double-blind, randomized clinical trials. It significantly improves the effectiveness of standard treatments for Ulcerative Colitis when used in association with high-dose conventional anti-inflammatory or immunosuppressive treatment. It has been shown to be efficacious even alone in stopping an onset of the disease ⁽¹⁾ and also in preventing relapses ⁽²⁾. However, in the course of their disease, a high proportion of patients suffering from UC have to undergo proctocolectomy with the creation of a substitution reservoir: an ileal pouch anal anastomosis ( IPAA). Unfortunately, pouchitis is a serious complication whose frequency increases with the time from the intervention, affecting about 50% of patients at 10 years after surgery. Admittedly, some antibiotic treatments can treat pouchitis, but it very often becomes chronic and recurrent.

My probiotic mixture has proved useful both in the primary prevention of pouchitis and in secondary prevention. It is remarkably effective in preventing the onset of the disease ⁽³⁾ and in preventing recurrence ^{(4, 5)}. The product acts by increasing the intestinal population of beneficial bacteria (lactobacilli, bifidobacteria, S. thermophilus)  ⁽⁴⁾, confirmed by genomic analysis which also showed a reduction of the deleterious fungal flora ⁽⁶⁾. In the mucosa of the pouch of patients taking this probiotic blend, there is also an increase in the tissue level of protective mediators such as interleukin-10, as well as a decrease in the level of pro-inflammatory cytokines and activity of various metalloproteins such as that of NO-synthase which promotes local vasodilation ⁽⁷⁾.

The scientific corpus reporting the importance of my product for the management of the infectious complications of Ulcerative Colitis has grown over time and its mechanism of action is better understood. Its interest in the prevention of pouchitis and maintenance of remission has been confirmed in children ⁽⁸⁾. In adults, it allowed more than 2/3 of the patients (16 out of 23) on probiotic supplementation alone but at a very high dose (3600 billion bacteria per day for 4 weeks) to enter into remission of their pouchitis ⁽⁹⁾.

These early data enabled the international scientific community to recognize the therapeutic importance of my probiotic mixture ^{(10,11,12,13,14)}. As a result, in the USA and the UK, medical guidelines include this specific blend for the prevention of pouchitis or as maintenance treatment for chronic pouchitis.

This probiotic has also shown real efficacy in the treatment of other disorders of the digestive tract, notably improving irritable bowel syndrome ^(15,16,17). Other data have been published for the management of liver diseases such as nonalcoholic hepatic steatosis ⁽¹⁸⁾ and hepatic encephalopathy ^{(19,20,21,22,23)}. Finally, it could contribute, like some non-steroidal anti-inflammatory drugs, to the prevention of the carcinological complications of pouchitis following the surgical treatment of familial adenomatous polyposis ⁽²⁴⁾.

More recent data have also been published regarding its mechanism of action. A proteomic approach revealed similar changes, after administration of probiotics and after antibiotic therapy, of the protein profile expressed in the mucus of patients with pouchitis ⁽²⁵⁾. The improvement in the PDAI index (“pouchitis disease activity index”) is correlated with the increase in the percentage of CD4 and CD25 regulatory lymphocytes, accompanied by a significant reduction in mRNA expression of interleukin-1β And an increase of that of Foxp3 ⁽²⁶⁾.

All these human clinical data and animal experiments confirm the therapeutic significance of this original mixture of eight probiotic strains, newly available in France under the name of Vivomixx® in particular as supplementation for patients with Ulcerative Colitis and pouchitis. ⁽²⁹⁾

Consequently, in the face of such pathologies, the use of a mixture of probiotics such as Vivomixx^® remains a valid option today ⁽³⁰⁾ and is still part of the recommendations updated at the 4th triennual consensus conference on the use of Probiotics, held in New Haven (USA) in March 2015.

Notes, see Clinical studies and publications concerning the blend of Prof. Claudio De Simone