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

This study has been completed.
Sponsor:
Collaborators:
American College of Gastroenterology
Texas Medical Center Digestive Disease Center
NASPGHAN Foundation
Information provided by (Responsible Party):
Bruno Chumpitazi, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01018498
First received: October 28, 2009
Last updated: May 11, 2013
Last verified: May 2013
  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 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.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: Restricted FODMAPs diet

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Improvement in pain frequency [ Time Frame: Prior to and after 1 week of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in GI Transit Time [ Time Frame: Prior to and after 1 week of treatment ] [ Designated as safety issue: No ]
  • Changes in Breath Hydrogen and Methane production [ Time Frame: Prior to and after 1 week of treatment ] [ Designated as safety issue: No ]
  • Changes in GI Permeability [ Time Frame: Prior to and after 1 week of treatment ] [ Designated as safety issue: No ]
  • Changes in fecal microbiome [ Time Frame: Prior to and after 1 week of treatment ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Restricted FODMAPs diet
Restricted fermentable substrate diet for 1 week
Behavioral: Restricted FODMAPs diet
Restricted fermentable substrate diet

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018498

Locations
United States, Texas
Children's Nutrition Research Center
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
American College of Gastroenterology
Texas Medical Center Digestive Disease Center
NASPGHAN Foundation
Investigators
Principal Investigator: Bruno P Chumpitazi, M.D., M.P.H. Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Bruno Chumpitazi, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01018498     History of Changes
Other Study ID Numbers: H-25005
Study First Received: October 28, 2009
Last Updated: May 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Irritable Bowel Syndrome
Children

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014