• Improvement in pain symptoms [ Time Frame: After 3 weeks of treatment ] [ Designated as safety issue: No ]
  

• Changes in GI Transit Time [ Time Frame: Prior to and after 3 weeks of treatment ] [ Designated as safety issue: No ]
  
• Changes in Breath Hydrogen production [ Time Frame: Prior to and after 3 weeks of treatment ] [ Designated as safety issue: No ]
  
• Changes in GI Permeability [ Time Frame: Prior to and after 3 weeks of treatment ] [ Designated as safety issue: No ]
  
• Changes in fecal microbiome [ Time Frame: Prior to and after 3 weeks of treatment ] [ Designated as safety issue: No ]
  
• Changes in fecal calprotectin [ Time Frame: Prior to and after 3 weeks of treatment ] [ Designated as safety issue: No ]
  
• Improvement in symptoms [ Time Frame: every 6 months after treatment up to 18 months after treatment completion ]
  

Up to 19% of school-aged children have recurrent abdominal pain (RAP), accounting for 5% of all pediatric office visits and increased morbidity. The majority of children with RAP have irritable bowel syndrome (IBS) with up to 60% these children going on to develop IBS as adults. IBS accounts for up to 8 billion dollars a year of healthcare costs in adults within the United States. Successful interventions that ameliorate symptoms in childhood IBS may have an impact into adulthood, however current clinical interventions are often ineffective.

As in adults, the etiology of childhood IBS is multi-factorial, with food intolerance and increased gastrointestinal inflammation being potential factors. Another factor, that of malabsorption of fermentable substrates (e.g., fructose), has frequently been postulated as a form of food intolerance that exacerbates IBS symptoms in adults and children. Studies suggest up to 61% of children with RAP have fructose malabsorption. The interactions between factors such as increased gastrointestinal inflammation and malabsorption of fermentable substrates and they relate to an individual patient is currently unknown.

Recently, a diet that lowers intake of a combination of foods has been found to be effective in adults with IBS identified with fructose malabsorption. This diet has not been used in children with IBS nor has its mechanism(s) of efficacy been explored. This pilot project focuses on using a restricted fermentable substrate diet as a treatment in children with IBS, while evaluating decreased bacterial fermentation gas production and decreased gastrointestinal inflammation as mechanisms of its effect.

Using a prospective, randomized (restricted fermentable substrate diet versus regular unrestricted diet), open label, controlled design in children with fructose malabsorption meeting Rome III childhood IBS criteria, our Specific Aims are to: 1) Characterize the effectiveness of a restricted FODMAPs diet in improving symptoms (number of abdominal pain episodes, severity of abdominal pain episodes; primary endpoints); 2) Ascertain whether a restricted FODMAPs diet decreases GI bacterial fermentation gas production (hydrogen and methane production measured via lactulose breath testing) and decreases GI inflammation (determined by fecal calprotectin concentration). We Hypothesize that: 1) A restricted FODMAPs diet will improve abdominal pain symptoms associated with childhood IBS and identified fructose malabsorption; 2) A restricted FODMAPs diet will improve symptoms in part by decreasing bacterial fermentation gas production and by decreasing gastrointestinal inflammation.

The results of this proposal may, if applied on a larger scale, aid a large number of children with IBS and potentially provide insight into the mechanism(s) behind successful dietary interventions for childhood IBS. Furthermore, findings from this pilot study can be used toward a developing a larger, randomized, double blind controlled trial that will investigate in more detail potential mechanisms whereby a restricted FODMAPs diet improves symptoms in children with IBS.