No drug is currently approved in the United States for the management of FD.1

FD is often a remitting-relapsing functional bowel disorder with no known organic cause. FD is a common, under-diagnosed,2 and under-managed disorder in the upper belly.

Functional Dyspepsia is the presence of symptoms that originate in the gastro-duodenal region in the absence of any organic or systemic disease that could explain the symptoms.

80% of persons with dyspepsia report that their symptoms are aggravated by the ingestion of a meal.3

According to the Rome IV criteria, symptoms include epigastric pain or discomfort, postprandial fullness and early satiety (cannot finish a normal sized meal) within the last 3 months, with symptom onset at least 6 months earlier. Other common symptoms include postprandial nausea, belching and abdominal bloating.



80% of persons with dyspepsia report that their symptoms are aggravated by the ingestion of a meal.3

The Distinctive Nutritional Requirements for People with FD

People with FD often do not eat regularly or normally, which may affect their normal intake of nutrients. Also, their digestion of food and absorption of nutrients may be affected due to motility disturbances in the GI tract. Patients with FD have been known to experience weight loss because of reduced food intake or retention of food.4

The inflammatory cascades5 (e.g. eosinophils in the duodena)6 related to FD are associated with permeability dysfunction, which, in turn, affects the digestion and absorption of nutrients.

Deficiency of folate and B12 has been shown in FD. There is an association of other micronutrient deficiencies and FD.7

There is increasing evidence that impaired mucosal defense mechanisms are implicated in the pathogenesis of functional gastrointestinal disorders (FGIDs), allowing inappropriate immune activation.8,9

More recently, perturbations of GI microbiota, altered mucosal permeability and abnormal mucosal defense mechanisms have been implicated in the pathogenesis of some FGIDs.10-15

Dietary modification alone, as a management strategy, has had mixed success. Fiber is helpful. Exclusionary diets help in the short term but lead to nutritional imbalances and adherence issues in the long-term. Diet alone does not address the complex disruptions of the upper belly.16

To effectively manage FD, it is important to help normalize the gut mucosal barrier dysfunction and its associated localized, reversible, low-grade inflammation.6

Now, doctors increasingly use medical foods, such as FDgard, to help normalize the digestion and absorption of food nutrients and to help manage FD symptoms.

FDgard is specially formulated to meet the distinctive nutritional requirements of FD that cannot be met with dietary modification, alone. FDgard is designed to supply microspheres of caraway oil and l-Menthol, along with fiber and amino acids (from gelatin protein), to the upper belly. The anti-inflammatory,17 anti-spasmodic,18 and visceral analgesic properties19 of caraway oil and l-Menthol, help toward normalizing the digestion and absorption of food nutrients, and to manage the symptoms of FD.

By improving gut health in the first place, FDgard helps prevent nutritional problems later.


1 Lacy, B E, N J Talley, G R Locke Iii, E P Bouras, J K Dibaise, H B El-Serag, B P Abraham, C W Howden, P Moayyedi, and C Prather. 2012. “Current Treatment Options and Management of Functional Dyspepsia.” Aliment Pharmacol Ther 36 (3). Blackwell Publishing Ltd: 3–15. doi:10.1111/j.1365-2036.2012.05128.x.

2 Pleyer, C., H. Bittner, G. R. Locke, R. S. Choung, A. R. Zinsmeister, C. D. Schleck, L. M. Herrick, and N. J. Talley. 2014. “Overdiagnosis of Gastro-Esophageal Reflux Disease and Underdiagnosis of Functional Dyspepsia in a USA Community.” Neurogastroenterology and Motility 26 (8): 1163–71. doi:10.1111/nmo.12377.

3 Bisschops, R, G Karamanolis, J Arts, P Caenepeel, K Verbeke, J Janssens, and J Tack. 2008. “Relationship between Symptoms and Ingestion of a Meal in Functional Dyspepsia.” Gut 57 (11): 1495–1503. doi:10.1136/gut.2007.137125.

4 Brun, Rita, and Braden Kuo. 2010. “Functional Dyspepsia.” Therapeutic Advances in Gastroenterology 3 (3): 145–64. doi:10.1177/1756283X10362639.

5 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.

6 Talley, NJ, MM Walker, and G Holtmann. 2016. “Functional Dyspepsia.” Curr Opin Gastroenterol 32 (4): 467–73. doi:10.1016/0300-2977(95)00099-9.

7 Rasool, Shahid, Shahab Abid, Mohammad Perwaiz Iqbal, Naseema Mehboobali, Ghulam Haider, and Wasim Jafri. 2012. “Relationship between Vitamin B12, Folate and Homocysteine Levels and H. Pylori Infection in Patients with Functional Dyspepsia: A Cross-Section Study.” BMC Research Notes 5 (1): 206. doi:10.1186/1756-0500-5-206.

8 Bischoff, Stephan C, Giovanni Barbara, Wim Buurman, Theo Ockhuizen, Jörg-Dieter Schulzke, Matteo Serino, Herbert Tilg, Alastair Watson, and Jerry M Wells. 2014. “Intestinal Permeability – a New Target for Disease Prevention and Therapy.” BMC Gastroenterology 14 (1): 189. doi:10.1186/s12876-014-0189-7.

9 Kindt, S., A. Tertychnyy, G. De Hertogh, K. Geboes, and J. Tack. 2009. “Intestinal Immune Activation in Presumed Post-Infectious Functional Dyspepsia.” Neurogastroenterology and Motility 21 (8): 832–38. doi:10.1111/j.1365-2982.2009.01299.x

10 Kassinen A, Krogius-Kurikka L, Makivuokko H, et al., The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subject. Gastroenterology 2007; 133:24-33.

11 Annahazi A, Ferrier L, Bezirard V, et al. Luminal cysteine-proteases degrade colonic tight junction structure and are responsible for andominal pain in constipation-predominant IBS. Am J Gastroenterol 2013; 108:1322-31.

12 Lee H, Park JH, Park DI, et al. Mucosal mast cell count is associated with intestinal permeability in patients with diarrhea predominant irritable bowel syndrome. Neurogastroenterol Motil 2013; 19:244-50.

13 Matricon J, Meleine M, Gelot A, et al. Review article: associations between immune activation, intestinal permeability and the irritable bowel syndrome. Aliment Pharmacol Ther 2012; 36:1009-31.

14 Vanheel H, Vicario M, Vanuytsel T, et al. Impaired duodenal mucosal integrity and low-grade inflammation in functional dyspepsia. Gut 63 2014: 262-271; doi:10.1136/gutjnl-2012-303857.

15 Martinez C, Lobo B, Pigrau M, et al. Diarrhoea-predominant irritable bowel syndrome: an organic disorder with structural abnormalities in the jejunal epithelial barrier. Gut 2012; 62:1160-8.

16 Shepherd, Susan J., and Peter R. Gibson. 2006. Journal of the American Dietetic Association 106 (10): 1631–39. doi:10.1016/j.jada.2006.07.010.

17 Talley, NJ, MM Walker, and G Holtmann. 2016. “Functional Dyspepsia.” Curr Opin Gastroenterol 32 (4): 467–73. doi:10.1016/0300-2977(95)00099-9.

18 Goerg, K. J., and Th Spilker. 2003. “Effect of Peppermint Oil and Caraway Oil on Gastrointestinal Motility in Healthy Volunteers: A Pharmacodynamic Study Using Simultaneous Determination of Gastric and Gall-Bladder Emptying and Orocaecal Transit Time.” Alimentary Pharmacology and Therapeutics. doi:10.1046/j.1365-2036.2003.01421.x.

19 Adam, Birgit, Tobias Liebregts, Jan Best, Lars Bechmann, Carolin Lackner, Jens Neumann, Stephan Koehler, and Gerald Holtmann. 2006. “A Combination of Peppermint Oil and Caraway Oil Attenuates the Post-Inflammatory Visceral Hyperalgesia in a Rat Model.” Scandinavian Journal of Gastroenterology 41 (2): 155–60. doi:10.1080/00365520500206442.