A scientific breakthrough in the management of Functional Dyspepsia (FD).

Recent scientific investigations have identified the gastro-duodenal region as the site of disruption in FD.

The older thinking in the healthcare community was that the site of disturbance in FD was primarily in the stomach.

Recent thinking in FD has been enabled by new tools such as confocal laser endomicroscopy,1,2 staining of immune cells,3 targeted biopsies,4 and genotypic/phenotypic correlations.5 With the use of these new tools it has been shown that gut barrier disruption and reversible, localized, low-grade immune activation are associated with FD.

The more recent scientific investigations reveal that the typical epicenter of the disturbance in FD is the gastro-duodenal region, while the visceral sensitivity involves the entire GI tract.6 In addition, it is now known that the dysmotility7,8 and abnormal permeability (intestinal malabsorption)3 observed in FD is localized in the duodenum. Gut mucosal barrier disruption can cause motility dysfunction (spasms) and irritated nerve endings (abdominal pain and cramps). All of this also involves in the impaired ability to digest and absorb food nutrients.9

FDgard® utilizes breakthrough targeted delivery science via SST® (Site Specific Targeting) technology. Never before has caraway oil and l-Menthol been formulated into individually enteric-coated microspheres, delivered where they are needed most in FD–in the duodenum.

Caraway oil and peppermint oil (primary component: l-Menthol) have been shown in multiple studies to be effective for people with FD.10 The d-Carvone and d-Limonene in caraway oil and l-Menthol are designed to work locally on the disrupted gut mucosal barrier and associated localized, reversible, low-grade inflammation, seen with FD, to deliver their calming properties to the site where the digestion and absorption of food nutrients is disturbed and where visceral sensitivity, (especially abdominal pain, discomfort, and cramping), originates.




Anatomical diagram showing site of disturbance in FD and pill spill

Caraway oil and l-Menthol targeted to the
gastro-duodenal region – the site of
disturbance in FD.

1 Nguyen, Nam Q., and Rupert W L Leong. 2008. “Current Application of Confocal Endomicroscopy in Gastrointestinal Disorders.” Journal of Gastroenterology and Hepatology (Australia) 23 (10): 1483–91. doi:10.1111/j.1440-1746.2008.05469.x.

2 Ji, Rui, Tao Yu, Xiao Meng Gu, Xiu Li Zuo, Kun An, Cheng Jun Zhou, and Yan Qing Li. 2011. “Gastric Metaplasia of the Duodenum: In Vivo Diagnosis by Endomicroscopy and Its Relationship with Functional Dyspepsia.” Journal of Gastroenterology and Hepatology (Australia) 26 (1): 73–77. doi:10.1111/j.1440-1746.2010.06479.x.

3 Vanheel, Hanne, Maria Vicario, Tim Vanuytsel, Lukas Van Oudenhove, Cristina Martinez, Åsa V Keita, Nicolas Pardon, et al. 2014. “Impaired Duodenal Mucosal Integrity and Low-Grade Inflammation in Functional Dyspepsia.” Gut 63 (2): 262–71. doi:10.1136/gutjnl-2012-303857.

4 Yantiss, Rhonda K, and Robert D Odze. 2009. “Optimal Approach to Obtaining Mucosal Biopsies for Assessment of Inflammatory Disorders of the Gastrointestinal Tract.” The American Journal of Gastroenterology 104 (3): 774–83. doi:10.1038/ajg.2008.108.

5 Lelyveld, N. Van, J. T. Linde, M. Schipper, and M. Samsom. 2008. “Candidate Genotypes Associated with Functional Dyspepsia.” Neurogastroenterology and Motility 20 (7): 767–73. doi:10.1111/j.1365-2982.2008.01102.x.

6 Trimble, K C, R Farouk, A Pryde, S Douglas, and R C Heading. 1995. “Heightened Visceral Sensation in Functional Gastrointestinal Disease Is Not Site-Specific.” Digestive Diseases and Sciences 40 (8). Springer: 1607–13.

7Stanghellini, V, C Ghidini, M R Maccarini, G F Paparo, R Corinaldesi, and L Barbara. 1992. “Fasting and Postprandial Gastrointestinal Motility in Ulcer and Non-Ulcer Dyspepsia.” Gut 33 (2): 184–90. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1373927&tool=pmcentrez&rendertype=abstract.

8 Bassotti, Gabrio, Maria Antonietta Pelli, and Antonio Morelli. 1990. “Duodenojejunal Motor Activity in Patients with Chronic Dyspeptic Symptoms.” Journal of Clinical Gastroenterology 12 (1). LWW: 17–21.

9 Groschwitz, Katherine R, and Simon P Hogan. 2009. “Intestinal Barrier Function: Molecular Regulation and Disease Pathogenesis.” The Journal of Allergy and Clinical Immunology 124 (1): 3-20-2. doi:10.1016/j.jaci.2009.05.038.

10 Thompson Coon, J, and E Ernst. 2002. “Systematic Review: Herbal Medicinal Products for Non-Ulcer Dyspepsia.” Alimentary Pharmacology & Therapeutics 16 (10): 1689–99. doi:10.1046/j.0269-2813.2002.01339.x.