Subject : Understanding the patient profile in irritable bowel
syndrome patients treated with VSL#3 - A multicenter, retrospective, cross-sectional study
IBS is one of the most commonly diagnosed gastrointestinal (GI) conditions and also one of the most common functional GI disorders seen in clinical practice.1 IBS is characterized by chronic or recurrent abdominal pain related to defecation, associated with change in frequency or form of stool. The etiology of irritable bowel syndrome (IBS) is thought to be multifactorial, with several factors including alterations in gut motility, small-bowel bacterial overgrowth, microscopic inflammation, and visceral hypersensitivity potentially playing a role.
Current approaches to diagnosis of IBS start with the identification of symptoms and the exclusion of organic disease in patients with “red-flags”. The treatment started with
non-pharmacological options including education, reassurance, and dietary modification. Pharmacological options are usually recommended if non-pharmacological methods alone have proven to be ineffective. Most of the current pharmacological therapies aim at treating the symptoms with the rationale of modulating intestinal motility and/or secretion, decreasing visceral sensitivity or treating associated disorders, such are anxiety and/or depression.
Patients with IBS may have alterations in the intestinal microbiota, thus leading investigators to consider targeting the intestinal microbiota for the treatment of this condition. So, patients with IBS may benefit from consuming high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. VSL#3 is a high-concentration probiotic preparation of eight live freeze-dried bacterial species that are normal components of the human gastrointestinal microflora, including four strains of lactobacilli, three strains of bifidobacteria and Streptococcus salivarius subsp. Thermophilus..
In this Retrospective cross-sectional observational study, we intend to understand the patient profile in Indian IBS patients treated with VSL#3
We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Case Record Form (CRF) provided, from the patient’s medical records (case papers and investigational reports — hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory investigations are available for the preceding 3 months.
We wish to inform you that the CRF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the CRF.
If you agree to participate in the said study, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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