Clinical Trial: Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome

Brief 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 Summary:

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 th
Sponsor: Baylor College of Medicine

Current Primary Outcome: Improvement in pain frequency [ Time Frame: Prior to and after 1 week of treatment ]

Original Primary Outcome: Improvement in pain symptoms [ Time Frame: After 3 weeks of treatment ]

Current Secondary Outcome:

  • Changes in GI Transit Time [ Time Frame: Prior to and after 1 week of treatment ]
  • Changes in Breath Hydrogen and Methane production [ Time Frame: Prior to and after 1 week of treatment ]
  • Changes in GI Permeability [ Time Frame: Prior to and after 1 week of treatment ]
  • Changes in fecal microbiome [ Time Frame: Prior to and after 1 week of treatment ]


Original Secondary Outcome:

  • Changes in GI Transit Time [ Time Frame: Prior to and after 3 weeks of treatment ]
  • Changes in Breath Hydrogen production [ Time Frame: Prior to and after 3 weeks of treatment ]
  • Changes in GI Permeability [ Time Frame: Prior to and after 3 weeks of treatment ]
  • Changes in fecal microbiome [ Time Frame: Prior to and after 3 weeks of treatment ]
  • Changes in fecal calprotectin [ Time Frame: Prior to and after 3 weeks of treatment ]
  • Improvement in symptoms [ Time Frame: every 6 months after treatment up to 18 months after treatment completion ]


Information By: Baylor College of Medicine

Dates:
Date Received: October 28, 2009
Date Started: October 2009
Date Completion:
Last Updated: May 11, 2013
Last Verified: May 2013