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

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.

Inclusion Criteria:

- Ages 7-17 years

- Meet criteria for Rome III irritable bowel syndrome

- 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