Adamas Biotech® has launched its first food supplement for individuals suffering from Irritable Bowel Syndrome associated with constipation (IBS-C) and, more generally, for the maintenance of intestinal function. The food supplement has been notified to the Ministry of Health and is now commercially available.
Adamas Biotech®’s innovative concept arises from the proposal of combining and leveraging the synergistic effects of patented and unique green tea extract, Theaphenon E®, and a probiotic mix to restore intestinal wellness in patients experiencing intestinal discomfort.
Irritable Bowel Syndrome – IBS
Irritable Bowel Syndrome (IBS) is one of the functional gastrointestinal disorders (FGIDs, i.e., not associated with structural or biochemical abnormalities detectable with current routine diagnostic tools) characterized by abdominal pain or discomfort, stool irregularities (consistency and frequency of defecations), and bloating (EFSA Panel on Dietetic Products, 2016).
IBS is often associated with other somatic comorbidities (e.g., pain syndromes, overactive bladder, chronic fatigue and migraine), psychiatric conditions (including depression and anxiety), and visceral hypersensitivity. IBS is a common disorder affecting millions of people worldwide, causing recurrent abdominal pain and alterations in bowel function (Bertin, Zanconato,, Crepaldi, Marasco, & Cremon, 2024).The prevalence of IBS is high (~11%) and has considerable consequences for quality of life (QoL), comparable to other chronic diseases. It affects approximately 5-15% of the Western population and is more prevalent in women under the age of 50 (Enck, Aziz, Barbara, Farmer, & Fukudo, 2016).
In 2016, the definition of Functional GI Disorders (FGIDs) evolved with the publication of the ROME IV criteria by the Rome Foundation. This update replaced FGID with a new term—Disorders of Gut-Brain Interaction (DGBI)—highlighting five key pathophysiological mechanisms: altered gut microbiota, altered central nervous system processing, altered mucosal and immune function, visceral hypersensitivity, and motility disturbances. This new definition further emphasizes the role of the gut-brain axis in intestinal disorders (Tuohya, et al., 2016)
Mechanisms and Pathophysiology
Although the exact etiology of IBS remains largely undefined, significant progress has been made in understanding the mechanisms underlying gut dysfunction, altered visceral sensation, and symptom generation. Emerging evidence indicates that in IBS, factors such as epithelial barrier integrity, gut microbiota composition, food antigens, and bile acids trigger abnormal responses in key regulators of sensorimotor function. These include the hypothalamus–pituitary–adrenal (HPA) axis, the immune system, the brain–gut axis, and the enteric nervous system (ENS), all of which play critical roles in gut homeostasis and symptom modulation (Barbara, Feinle-Bisset, Ghoshal, & Quigley, 2016).
Management Approaches
Only a fraction of individuals experiencing IBS-like symptoms (~50%) seek medical attention, with most initially consulting primary care physicians. The decision to seek medical care is often driven by symptom severity, particularly pain, the presence of alarm symptoms, and concerns about potential underlying serious conditions such as cancer.
Management strategies for IBS include a multidisciplinary approach, incorporating:
- Nutritional interventions to address dietary triggers and improve gut function.
- Pharmacological therapies, including antispasmodics, low-dose antidepressants, laxatives, motility accelerants, antidiarrheals, and microbiota-targeting treatments.
- Psychotherapy, which has shown benefits in symptom modulation and stress-related gut dysfunction.
Currently, no single definitive treatment exists for IBS, necessitating a holistic and personalized approach to symptom management and patient care (Enck, Aziz, Barbara, Farmer, & Fukudo, 2016).
Theakine® IBS-C
Theakine® IBS-C is a bi-component food supplement composed of proprietary green tea extract, Theaphenon E®, and probiotics, aiming to address different factors related to Irritable Bowel Syndrome associated with constipation (IBS-C). The food supplement is in capsule form, and the recommended dosage is two capsules per day: one containing probiotics and another one containing green tea extract.
Theaphenon E® is characterized by the highest degree of product purity (catechins 90-95% and epigallocatechin 3-gallate 65%) on the market, and absence of caffeine (<0.2%). The products undergo stringent analytical characterization. The green tea extract has been object of a quality evaluation in Italy to ascertain the safety and quality of the product. Catechins and their intestinal metabolites exhibit prebiotic properties by promoting the growth of beneficial gut microbiota, particularly Lactobacillus and Bifidobacteria. In addition to fostering a healthier microbial balance, they help reduce oxidative stress and inflammation, contributing to overall gut homeostasis. Furthermore, catechins play a role in strengthening the intestinal barrier, enhancing mucosal integrity and function. These combined effects highlight their potential in modulating gut microbiota and supporting gastrointestinal health (Sidhu, Vasundhara, & Dey, 2024)
Clinical studies have evaluated the effects of probiotics in patients with IBS associated with constipation, demonstrating symptom improvement through questionnaire-based assessments. These benefits persisted throughout a 30-day follow-up period. Microbiological analyses confirmed that probiotic strains present in the formulation, including Lactobacillus plantarum, Lactobacillus rhamnosus, and Bifidobacterium animalis subsp. lactis, significantly increased in the intestines of participants over a 60-day treatment period. Following treatment cessation, probiotic levels remained elevated for most strains, apart from B. animalis subsp. lactis, which exhibited a reduction This study demonstrated that the probiotics contained in Theakine® IBS-C are capable of colonizing the intestinal wall (Mezzasalma, et al., 2016). In vitro studies have further shown that this probiotic blend enhances pathogen inhibition while exerting antioxidant and anti-inflammatory effects.
The probiotics present in Adamas Biotech® food supplement have been successfully tested for long-term (24 months) stability at 25°C. Additionally, they have been shown in vitro to resist gastric acid and bile salts and have been tested in vivo to be capable of colonizing feces even 30 days after treatment cessation with positive results (Presti, et al., 2015). The gastro-resistant capsule guarantees an additional benefit by delivering probiotics directly to the intestine.
The Theakine® IBS-C project is an ambitious initiative aimed at securing a European health claim under Regulation (EC) No 1924/2006. In the coming months, a randomized, placebo-controlled clinical study will be conducted in accordance with EFSA guidelines. This study aims to evaluate symptomatology using a series of validated questionnaires while also analyzing specific biomarkers associated with alterations in intestinal homeostasis. By integrating both clinical and biological assessments, the study seeks to establish a cause-effect relationship, providing robust scientific evidence on the efficacy of Theakine® IBS-C food supplement.
Bibliography
Barbara, G., Feinle-Bisset, C., Ghoshal, U. C., & Quigley, E. M. (2016). The Intestinal Microenvironment and Functional Gastrointestinal Disorders. Gastroenterology.
Bertin, L., Z. M., Crepaldi, M., Marasco, G., & Cremon, C. (2024). The Role of the FODMAP Diet in IBS. Nutrients.
EFSA Panel on Dietetic Products, N. a. (2016). Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms. European Food Safety Authority.
Enck, P., Aziz, Q., Barbara, G., Farmer, A. D., & Fukudo, S. (2016). Irritable bowel syndrome. Nature reviews: Disease primers.
Mezzasalma, V., Manfrini, E., Ferri, E., Sandionigi, A., La Ferla, B., & Schiano, I. (2016). A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation. BioMed research international.
Presti, I., D’Orazio, G., Labra, M., La Ferla, B., Mezzasalma, V., Bizzaro, G., . . . Di Gennaro, P. (2015). Evaluation of the probiotic properties of new Lactobacillus and Bifidobacterium strains and their in vitro effect. Applied microbiology and biotechnology.
Sidhu, D., Vasundhara, M., & Dey, P. (2024). The intestinal-level metabolic benefits of green tea catechins: Mechanistic insights from pre-clinical and clinical studies. Phytomedicine.
Tuohya, K., Tuohy, K., Vaughan, E. E., Harthoorn, L. F., Blaak, E. E., & Burnet, P. W. (2016). Prebiotics in food and dietary supplements: a roadmap to EU health claims. Gut Microbes.
