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Restricted Fermentable Substrate Diet for Children With Irritable Bowel Syndrome (IBS) - NCT01018498-77030B(Clinical Trial 445298)



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City:  Houston
State:  
TX
Zip Code: 77030
Conditions: Irritable Bowel Syndrome - Fructose Malabsorption
Purpose: Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable bowel syndrome in adults and children. Recently, a diet known as a restricted fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet that lowers intake of a combination of fermentable substrates 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.
Study 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 known as a restricted fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet that lowers intake of a combination of fermentable substrates 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 FODMAPs 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 FODMAPs diet versus regular unrestricted diet), open label, controlled, 5 week 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.
Criteria: Inclusion Criteria: - Ages 7-12 - Meet criteria for irritable bowel syndrome - Fructose malabsorption - Negative physician evaluation within past year for abdominal pain Exclusion Criteria: - Diabetes or other problem requiring specialized diet - Red dye allergy - Unable to eat by mouth - Malnutrition or recent rapid weight loss - Psychotherapy for abdominal pain - Significant cognitive impairment or psychiatric co-morbidity - Frequent vomiting - History of suicide attempt - Non-English speaking parent or child - Chronic medical condition (excluding asthma) - Antibiotic usage, medicinal probiotic usage, or neuromodulator (e.g. amitriptyline) usage within the past 3 months - Start of or change in gastrointestinal medication (e.g. laxative) that may cause or ameliorate symptoms within the past month
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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