Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable bowel
      syndrome in adults and children. 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.

      The purpose of this study is to determine whether a restricted fermentable substrate diet is
      effective in the treatment of irritable bowel syndrome in children.
    

Detailed description: 
      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, open label design in children 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; primary endpoint); 2) To determine the
      mechanisms by which a restricted FODMAPs diet may work. 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 amongst other potential mechanisms.

      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.
    

Intervention name(s): Restricted FODMAPs diet
Intervention type(s): Behavioral
Intervention description(s): Restricted fermentable substrate diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Children