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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018498
• Other study ID #: H-25005
• Status: Completed
• Phase: N/A
• First received: October 28, 2009
• Last updated: January 16, 2018
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2018
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Restricted FODMAPs diet
Restricted fermentable substrate diet

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	American College of Gastroenterology, NASPGHAN Foundation, Texas Medical Center Digestive Disease Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chumpitazi BP, Hollister EB, Oezguen N, Tsai CM, McMeans AR, Luna RA, Savidge TC, Versalovic J, Shulman RJ. Gut microbiota influences low fermentable substrate diet efficacy in children with irritable bowel syndrome. Gut Microbes. 2014 Mar-Apr;5(2):165-75 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in pain frequency		Prior to and after 1 week of treatment
Secondary	Changes in GI Transit Time		Prior to and after 1 week of treatment
Secondary	Changes in Breath Hydrogen and Methane production		Prior to and after 1 week of treatment
Secondary	Changes in GI Permeability		Prior to and after 1 week of treatment
Secondary	Changes in fecal microbiome		Prior to and after 1 week of treatment