{"id":3053,"date":"2025-06-05T16:35:51","date_gmt":"2025-06-05T14:35:51","guid":{"rendered":"https:\/\/www.tgd.care\/non-categorizzato\/biointestil-real-life-study-2025\/"},"modified":"2025-06-06T09:34:30","modified_gmt":"2025-06-06T07:34:30","slug":"biointestil-real-life-study-2025","status":"publish","type":"post","link":"https:\/\/www.tgd.care\/en\/articles\/digestion\/biointestil-real-life-study-2025\/","title":{"rendered":"Real-Life Study: Effectiveness of BIOintestil\u00ae in the Management of IBS"},"content":{"rendered":"<p>To evaluate the effectiveness of BIOintestil\u00ae, a <strong>real-life, open-label study<\/strong> was conducted in collaboration with Italian gastroenterologists on patients experiencing symptoms consistent with Irritable Bowel Syndrome (IBS).<\/p>\n<p>IBS is currently the <strong>most common functional gastrointestinal disorder<\/strong>. It is a chronic and relapsing condition that, in the absence of identifiable organic causes, is diagnosed based on characteristic symptoms such as<\/p>\n<ul>\n<li><strong>altered gut motility<\/strong>,<\/li>\n<li><strong>visceral hypersensitivity<\/strong>,<\/li>\n<li><strong>abdominal bloating<\/strong>,<\/li>\n<li><strong>low-grade intestinal inflammation<\/strong> and<\/li>\n<li><strong>gut dysbiosis<\/strong>.<\/li>\n<\/ul>\n<p>You can learn more about this condition reading our article <strong><a href=\"https:\/\/www.tgd.care\/en\/articles\/ibs\/\" target=\"_blank\" rel=\"noopener\">&#8220;Irritable Bowel Syndrome: Symptoms, Causes, and Insights&#8221;<\/a><\/strong>.<\/p>\n<p>Today, <strong>symptom relief remains the primary therapeutic goal in IBS management<\/strong>. Treatment is tailored to each patient\u2019s clinical profile and typically involves a multidisciplinary approach. While conventional over-the-counter medications are commonly used for their accessibility, safety, and low cost, they may be limited by side effects, contraindications, and suboptimal long-term outcomes.<\/p>\n<p>In recent years, <strong>lifestyle interventions<\/strong> have gained recognition as effective <strong>first-line strategies<\/strong> in the management of IBS. Among these are <strong>dietary changes<\/strong> and <strong>increased physical activity<\/strong>, along with <strong>complementary approaches such as phytotherapy<\/strong>.<\/p>\n<h2>The Innovation Roadmap Behind the Real-Life Study<\/h2>\n<p>Current research has not yet clarified whether IBS-related dysbiosis is a cause or a consequence of intestinal inflammation. However, it is widely accepted that <strong>dysbiosis plays a key role in the pathophysiology of the disorder and likely contributes to the persistence of symptoms<\/strong>.<\/p>\n<p><strong>Essential oils<\/strong> have attracted growing interest in the management of gastrointestinal disorders due to their ability to <strong>modulate inflammation<\/strong>, <strong>oxidative stress<\/strong>, <strong>immune activation<\/strong>, and <strong>microbial imbalance<\/strong>. Among them, <strong>palmarosa essential oil<\/strong> (<em>Cymbopogon martinii<\/em>), which is particularly rich in geraniol, has shown promising pharmacological properties, including<\/p>\n<ul>\n<li><strong>selective antimicrobial<\/strong>,<\/li>\n<li><strong>anti-inflammatory<\/strong> and<\/li>\n<li><strong>antioxidant activity<\/strong>.<\/li>\n<\/ul>\n<p>In an <em>in vivo<\/em> model, oral administration of a low-absorbable geraniol formulation <strong>reduced intestinal wall Cyclooxygenase-2 (COX-2) expression<\/strong>, <strong>improved colitis<\/strong>, and <strong>favorably modulated gut dysbiosis<\/strong>. In a subsequent <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/30567535\/\" target=\"_blank\" rel=\"noopener\"><strong>pilot study<\/strong><\/a> on IBS patients, the same formulation <strong>reduced scores on the IBS-Visual Analog Scale (IBS-VAS)<\/strong> and led to <strong>significant improvements in quality of life<\/strong>.<\/p>\n<p><strong><a href=\"https:\/\/www.tgd.care\/en\/raw_materials\/biointestil\/\" target=\"_blank\" rel=\"noopener\">BIOintestil<\/a><a href=\"https:\/\/www.tgd.care\/en\/raw_materials\/biointestil\/\" target=\"_blank\" rel=\"noopener\">\u00ae<\/a><\/strong> was developed to <strong>optimize the delivery of palmarosa essential oil to the gut microbiota<\/strong>. Thanks to its very-low-absorbable formulation, the <a href=\"https:\/\/www.frontiersin.org\/journals\/pharmacology\/articles\/10.3389\/fphar.2018.00018\/full\" target=\"_blank\" rel=\"noopener\"><strong>systemic bioavailability of the essential oil<\/strong><\/a> -specifically geraniol &#8211; <strong>is reduced from 92% (free form) to just 16%<\/strong>, allowing approximately 85% of the active compound to reach the colon intact.<\/p>\n<h2>From Controlled Trial to Real-World Evidence<\/h2>\n<p>The efficacy of BIOintestil was initially demonstrated in a <a href=\"https:\/\/www.mdpi.com\/2072-6643\/14\/19\/4208\" target=\"_blank\" rel=\"noopener\"><strong>double-blind, randomized, placebo-controlled clinical trial<\/strong><\/a> involving 56 IBS patients. The treatment led to a <strong>significant reduction in symptom severity<\/strong>\u2014assessed through the <strong>IBS Severity Scoring System (IBS-SSS)<\/strong>\u2014and produced <strong>beneficial changes in gut microbiota composition<\/strong>.<\/p>\n<p>To confirm these findings under everyday conditions, a broader real-life open-label study was launched, involving a larger population of IBS patients.<\/p>\n<h2>Experimentation keypoints<\/h2>\n<p>The study was an <strong>interventional multicenter clinical trial conducted in an open-label manner with a dietary supplement based on BIOintestil\u00ae (<a href=\"https:\/\/www.diademafarma.it\/en\" target=\"_blank\" rel=\"noopener\">Eurekol\u00ae<\/a>, <\/strong>distributed in Italy by Diadema Farmaceutici s.r.l.).\u00a0The study population consisted of <strong>patients diagnosed with IBS<\/strong>, enrolled by 31 private Italian gastroenterologists. Each patient in the study was administered a food supplement based on BIOintestil<strong>\u00ae<\/strong> <strong>for 30 days<\/strong>.<br \/>\nThe severity of IBS was calculated using the validated IBS-SSS questionnaire. All details regarding timelines, study design, IBS-SSS Questionnaire scoring, and inclusion\/exclusion criteria are provided in the infographic below.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-3055 size-full\" style=\"letter-spacing: 0em;\" src=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/ENG-materials-and-methods-Ricci-et-al.-2025.jpg\" alt=\"BIOintestil study design infographic\" width=\"1200\" height=\"800\" srcset=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/ENG-materials-and-methods-Ricci-et-al.-2025.jpg 1200w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/ENG-materials-and-methods-Ricci-et-al.-2025-300x200.jpg 300w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/ENG-materials-and-methods-Ricci-et-al.-2025-1024x683.jpg 1024w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/ENG-materials-and-methods-Ricci-et-al.-2025-600x400.jpg 600w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/ENG-materials-and-methods-Ricci-et-al.-2025-900x600.jpg 900w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<p><em>Figure 1 \u2013 The infographic illustrates the study design, the dosage of the formulation used, the study objectives, and the inclusion and exclusion criteria applied for enrollment. It also includes a description of the IBS-SSS questionnaire.<\/em>&nbsp;<\/p>\n<h2>Results of the Real-Life Study<\/h2>\n<p>Statistical analyses identified <strong>significant differences in the participants\u2019 symptomatology between V1 and V2. <\/strong>During the treatment with BIOintestil\u00ae, <strong>the average symptomatology score of the disease changed positively from moderate to mild severity<\/strong>.<br \/>\nFigures below demonstrate a highly significant reduction, with <strong>p-value &lt; 0.01<\/strong>, in the total score after the 30 days of treatment, with the <strong>mean value dropping from 238.66 \u00b1 82.91 to 76.69 \u00b1 65.35 <\/strong>(Figure 2). The trial confirmed the same highly significant result (p &lt; 0.01) in each IBS subtype (Figures 3 to 6). In particular, <strong>patients with IBS-U reported the greatest benefits<\/strong>.<\/p>\n<figure id=\"attachment_3058\" aria-describedby=\"caption-attachment-3058\" style=\"width: 900px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3058 size-us_900_900\" src=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/mean-results-IBS-SSS-900x600.jpg\" alt=\"mean IBS-SSS results real-life study \" width=\"900\" height=\"600\" srcset=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/mean-results-IBS-SSS-900x600.jpg 900w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/mean-results-IBS-SSS-300x200.jpg 300w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/mean-results-IBS-SSS-1024x683.jpg 1024w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/mean-results-IBS-SSS-600x400.jpg 600w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/mean-results-IBS-SSS.jpg 1200w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><figcaption id=\"caption-attachment-3058\" class=\"wp-caption-text\"><em>Figure 2 \u2013 Comparison of the mean scores for each criterion of the IBS-SSS questionnaire and the total score at the first visit (V1) and the second visit (V2).<\/em><\/figcaption><\/figure>\n<figure id=\"attachment_3061\" aria-describedby=\"caption-attachment-3061\" style=\"width: 900px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3061 size-us_900_900\" src=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-C-900x600.jpg\" alt=\"IBS-SSS Results \u2013 IBS-C Subtype \u2013 BIOintestil Real-Life Study\" width=\"900\" height=\"600\" srcset=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-C-900x600.jpg 900w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-C-300x200.jpg 300w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-C-1024x683.jpg 1024w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-C-600x400.jpg 600w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-C.jpg 1200w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><figcaption id=\"caption-attachment-3061\" class=\"wp-caption-text\"><em>Figure 3 \u2013 Comparison of the scores for each criterion of the IBS-SSS questionnaire and the total score at the first visit (V1) and the second visit (V2) for the IBS-C subtype.<\/em><\/figcaption><\/figure>\n<figure id=\"attachment_3064\" aria-describedby=\"caption-attachment-3064\" style=\"width: 900px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3064 size-us_900_900\" src=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-D-900x600.jpg\" alt=\"IBS-SSS Results \u2013 IBS-D Subtype \u2013 BIOintestil Real-Life Study\" width=\"900\" height=\"600\" srcset=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-D-900x600.jpg 900w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-D-300x200.jpg 300w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-D-1024x683.jpg 1024w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-D-600x400.jpg 600w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-D.jpg 1200w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><figcaption id=\"caption-attachment-3064\" class=\"wp-caption-text\"><em>Figure 4 \u2013 Comparison of the scores for each criterion of the IBS-SSS questionnaire and the total score at the first visit (V1) and the second visit (V2) for the IBS-D subtype.<\/em><\/figcaption><\/figure>\n<figure id=\"attachment_3067\" aria-describedby=\"caption-attachment-3067\" style=\"width: 900px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3067 size-us_900_900\" src=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-M-900x600.jpg\" alt=\"IBS-SSS Results \u2013 IBS-M Subtype \u2013 BIOintestil Real-Life Study\" width=\"900\" height=\"600\" srcset=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-M-900x600.jpg 900w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-M-300x200.jpg 300w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-M-1024x683.jpg 1024w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-M-600x400.jpg 600w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-M.jpg 1200w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><figcaption id=\"caption-attachment-3067\" class=\"wp-caption-text\"><em>Figure 5 \u2013 Comparison of the scores for each criterion of the IBS-SSS questionnaire and the total score at the first visit (V1) and the second visit (V2) for the IBS-M subtype.<\/em><\/figcaption><\/figure>\n<figure id=\"attachment_3070\" aria-describedby=\"caption-attachment-3070\" style=\"width: 900px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3070 size-us_900_900\" src=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-U-900x600.jpg\" alt=\"IBS-SSS Results \u2013 IBS-U Subtype \u2013 BIOintestil Real-Life Study\" width=\"900\" height=\"600\" srcset=\"https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-U-900x600.jpg 900w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-U-300x200.jpg 300w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-U-1024x683.jpg 1024w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-U-600x400.jpg 600w, https:\/\/www.tgd.care\/wp-content\/uploads\/2025\/06\/IBS-SSS-IBS-U.jpg 1200w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><figcaption id=\"caption-attachment-3070\" class=\"wp-caption-text\">Figure 6 \u2013 Comparison of the scores for each criterion of the IBS-SSS questionnaire and the total score at the first visit (V1) and the second visit (V2) for the IBS-U subtype.<\/figcaption><\/figure>\n<p>&nbsp;<\/p>\n<p>These data must be interpreted considering the open-label experimental design and the absence of a placebo arm. Considering these factors, we can reasonably consider a <strong>placebo effect of approximately 35%<\/strong>. In this scenario, <strong>the actual efficacy of BIOintestil\u00ae could be estimated at about 40% of responders<\/strong>. Overall, the observed improvement in IBS symptomatology and QoL associated with the pharmacological effects of BIOintestil\u00ae are in line with results from our previously reported clinical trials.<\/p>\n<p>Questi dati devono essere interpretati considerando il disegno sperimentale in aperto e l\u2019assenza di un braccio placebo. Tenendo conto di questi fattori, possiamo ragionevolmente considerare un<strong> effetto placebo di circa il 35%<\/strong>. In questo scenario, l\u2019<strong>efficacia reale di BIOintestil\u00ae potrebbe essere stimata intorno al 40% di responder<\/strong>. Complessivamente, il miglioramento osservato nella sintomatologia dell\u2019IBS e nella qualit\u00e0 della vita, associato agli effetti di BIOintestil\u00ae, \u00e8 coerente con i risultati dei nostri precedenti studi clinici.<\/p>\n<h2>Bibliography<\/h2>\n<p>Ricci, C.; Saracino, I.M.; Valerii, M.C.; Spigarelli, R.; Bellocchio, I.; Spisni, E. <strong>Very-Low-Absorbable Geraniol for the Treatment of Irritable Bowel Syndrome: A \u201cReal-World\u201d Open-Label Study on 1585 Patients<\/strong>. Nutrients 2025, 17, 328. <a href=\"https:\/\/doi.org\/10.3390\/nu17020328\" target=\"_blank\" rel=\"noopener\">https:\/\/doi.org\/10.3390\/nu17020328<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>To evaluate the effectiveness of BIOintestil\u00ae, a real-life, open-label study was conducted in collaboration with Italian gastroenterologists on patients experiencing symptoms consistent with Irritable Bowel Syndrome (IBS). IBS is currently the most common functional gastrointestinal disorder. It is a chronic and relapsing condition that, in the absence of identifiable organic causes, is diagnosed based on&#8230;<\/p>\n","protected":false},"author":2,"featured_media":3048,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-3053","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-digestion"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Real-Life Study:Effectiveness of BIOintestil\u00ae in Management of IBS<\/title>\n<meta name=\"description\" content=\"Real-life study on BIOintestil\u00ae: read the results on reducing symptoms of Irritable Bowel Syndrome and improving patients&#039; quality of life.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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