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The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide.
The aim of this randomised, double-blind, placebo-controlled, multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period will be randomly allocated to receive blinded treatment Enterosgel® or placebo for 8 weeks.
This will be followed by an 8-week open-label treatment phase with Enterosgel®.
Participants will be allowed to adjust their daily dosage during both phases based diabetes research and clinical practice if their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 cukorbetegség és gyógynövények kezelés later. Co-medication with loperamide will be permitted and use recorded.
The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase.
Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers and gut-related measurements from magnetic resonance imaging data.
A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion.
Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions. Prospectively registered on 14 November The specific cause of the disorder is not fully understood [ 45 ], but among other factors may include genetic disposition, gut immune dysfunction, immune activation, gut dysbiosis, infective and dietary triggers and changes to gut permeability [ 6 — 8 ].
IBS is common worldwide, with an estimated prevalence globally of It occurs in all age groups, including children and the elderly, although it predominantly affects adults of working age. The prevalence of each subtype can vary depending on the classification used.
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Overall healthcare costs for IBS are comparable to those of other chronic diseases with a similar prevalence, such as congestive heart failure, hypertension, asthma and migraine [ 16 ].
IBS is a challenging condition to treat mainly as a result of its complex multi-factorial nature. Currently, no single universally effective approach is available for the management of IBS [ 13 ], but lifestyle or dietary changes are often implemented as the first step of management.
Probiotic use is also becoming more common and has shown to improve symptoms in patients with IBS-D [ 17 ]. Potential treatment targets include mediators such as histamine and serotonin, which are postulated to play a causative role in IBS, and bacterial products and bile acids, which also have been implicated in the generation of IBS symptoms [ 78 ].
Medications for treating IBS-related symptoms include antispasmodics, psychotropic agents, bulking agents and 5-HT receptor antagonists. However, many of these drugs have proven to be inadequate for the relief of symptoms and some have safety issues [ 18 ].
There is, therefore, a need for well-designed clinical trials on new therapies for IBS-D. Previous clinical studies on intestinal adsorbents have shown some improvement in the symptoms of IBS-D, but are likely to have been underpowered for many important outcome measures [ 2324 ].
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The rationale for the use of intestinal adsorbents in the management of IBS symptoms is their ability to bind to various mediators and toxins and remove them from the gastrointestinal tract in the stools. There is also evidence from research on the intestinal adsorbent dioctahedral smectite for enhancement of the intestinal barrier function, which counteracts disruption from pro-inflammatory cytokines [ 2526 ].
One of the intestinal adsorbents approved for use in IBS-D and available over-the-counter in the UK is Enterosgel®, which is a drug-free treatment developed for binding toxins and other harmful substances in the gastrointestinal diabetes research and clinical practice if [ 27 ].
It is suitable for different patient groups, including children and the elderly.
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Although there has been extensive research on Enterosgel®, including two pilot studies in IBS-D reporting a normalisation of stool frequency and form and decrease in bodily pain [ 2829 ], and a UK based study in acute diarrhoea [ 30 ], so far none of the conducted studies have included a placebo control arm. The difficulty has been that gel-like substances with a consistency similar to commercially available Enterosgel® for example gelatin or starch based could potentially have effects in the gastrointestinal tract and their suitability for use as a placebo would require validation.
This randomised, double-blind, placebo-controlled, multi-centre study will use an innovative approach to overcome this challenge. The aim is to test the efficacy and safety of Enterosgel® over placebo in symptomatic treatment in adults with IBS-D diagnosed according to the Rome IV criteria.
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The study involves a 2-week screening phase, after which eligible participants are randomised to blinded treatment Enterosgel® or placebo for 8 weeks. Following the double-blind treatment phase, all participants will receive open-label Enterosgel® treatment for a further 8 weeks.
At the end of the open-label treatment phase, all participants will return to standard care; however, those who responded to open-label treatment will receive a follow-up call 8 weeks later.