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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01018498
Enrollment
12
Registered
2009-11-23
Start date
2009-10-31
Completion date
2011-09-30
Last updated
2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Children

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 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.

Interventions

BEHAVIORALRestricted FODMAPs diet

Restricted fermentable substrate diet

Sponsors

American College of Gastroenterology
CollaboratorOTHER
Texas Medical Center Digestive Disease Center
CollaboratorUNKNOWN
NASPGHAN Foundation
CollaboratorOTHER_GOV
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Improvement in pain frequencyPrior to and after 1 week of treatment

Secondary

MeasureTime frame
Changes in GI Transit TimePrior to and after 1 week of treatment
Changes in Breath Hydrogen and Methane productionPrior to and after 1 week of treatment
Changes in GI PermeabilityPrior to and after 1 week of treatment
Changes in fecal microbiomePrior to and after 1 week of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026