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DE SIMONE FORMULATION NAMED IN AGA CLINICAL PRACTICE GUIDELINES ON MANAGEMENT OF
POUCHITIS AND INFLAMMATORY POUCH DISORDERS

May 31, 2024

By: Jenna Sheldon, DO, MS



Pouchitis is an inflammatory condition that may occur in patients who have
undergone an ileal pouch anal anastomosis (IPAA). The symptoms associated with
pouchitis can be debilitating for patients and treatment options, especially for
those who have symptoms resistant to antibiotics, are limited.  The De Simone
Formulation found only in Visbiome high potency probiotics, was recently named
in the American Gastrointestinal Association (AGA) Clinical Practice Guidelines
on Management of Inflammatory Pouch Disorders. These guidelines are developed
from a multidisciplinary panel of experts utilizing the Grading of
Recommendations Assessment, Development, and Evaluation (GRADE) system to
analyze existing evidence and develop recommendations for the prevention and
treatment of pouchitis.

 Within their newly updated recommendations for prevention of pouchitis, the AGA
guidelines “suggests using probiotics for preventing recurrent pouchitis”,
specifically citing the De Simone Formulation as the multi-strain probiotic
utilized in the clinical trials they reviewed to devise this recommendation.
This recommendation is intended for patients with UC who have undergone IPAA and
experience recurrent episodes of pouchitis. One of the studies referenced by the
AGA includes utilizing antibiotics, ciprofloxacin, and rifaximin daily to
achieve endoscopic remission prior to patients receiving the De Simone
Formulation (Gionchetti et al., 2000). The guidelines also reference a similar
study by Mimura et al. which utilized two different antibiotics, metronidazole
and ciprofloxacin to achieve remission prior to randomizing patients to
receiving the De Simone Formulation vs Placebo. The third study referenced,
conducted by Pronio et al., examines the efficacy of the De Simone Formulation
in post-surgery patients at various time periods who were not taking any
medications before study entry. In summary, the AGA guidelines highlighted that
this data supports utilizing the De Simone Formulation for preventing the
recurrence of pouchitis in antibiotic-responsive patients, noting that the
recommendation is conditional.

Probiotics are at the forefront of many clinical trials currently, with evidence
surrounding their effectiveness in various disease states steadily increasing.
The De Simone Formulation has been the subject of clinical trials involving
nearly 500 adult and 47 pediatric patients. The makers of the De Simone
Formulation, ExeGi Pharma, continue to prioritize research and development of
microbiome science. The inclusion of the De Simone Formulation in the AGA
Clinical Practice Guidelines on the management of Pouchitis and Inflammatory
Pouch Disorders will hopefully highlight this high potency probiotic and its
important indications for healthcare providers and patients looking to manage
this condition.

References:

Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G,
Poggioli G, Miglioli M, Campieri M. Oral bacteriotherapy as maintenance
treatment in patients with chronic pouchitis: a double-blind, placebo-controlled
trial. Gastroenterology. 2000 Aug;119(2):305-9. doi: 10.1053/gast.2000.9370.
PMID: 10930365. 

Mimura T, Rizzello F, Helwig U, Poggioli G, Schreiber S, Talbot IC, Nicholls RJ,
Gionchetti P, Campieri M, Kamm MA. Once daily high dose probiotic therapy
(VSL#3) for maintaining remission in recurrent or refractory pouchitis. Gut.
2004 Jan;53(1):108-14. doi: 10.1136/gut.53.1.108. PMID: 14684584; PMCID:
PMC1773918.

Pronio A, Montesani C, Butteroni C, Vecchione S, Mumolo G, Vestri A, Vitolo D,
Boirivant M. Probiotic administration in patients with ileal pouch-anal
anastomosis for ulcerative colitis is associated with expansion of mucosal
regulatory cells. Inflamm Bowel Dis. 2008 May;14(5):662-8. doi:
10.1002/ibd.20369. PMID: 18240282. 

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ExeGi Pharma is a biotechnology company focused on the development and
commercialization of live biotherapeutic and probiotic medicines.

Important Safety Information
This product should not be used in premature infants in the Neonatal Intensive
Care Unit (NICU) setting.

Possible Side Effects
You may experience bloating during the first few days after starting Visbiome as
your intestinal microflora changes. If this occurs, you may need to reduce daily
consumption to allow for adjustment. Please consult with your physician if you
experience bloating.

Avoid taking at the same time as antibiotics. Certain strains contained in
Visbiome® may be inactivated by some types of antibiotics. It is advised that
you do not consume Visbiome® within 4 hours before or after taking antibiotics.

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