Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Baylor College of Medicine
Sponsor:
Collaborator:
NASPGHAN Foundation
Information provided by (Responsible Party):
Bruno Chumpitazi, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01339117
First received: April 14, 2011
Last updated: May 11, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.


Condition Intervention
Irritable Bowel Syndrome
Abdominal Pain
Other: Low fermentable substrate diet
Other: High fermentable substrate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Delivered 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:
  • Average daily abdominal pain frequency [ Time Frame: 9 days (2 dietary intervention periods) ] [ Designated as safety issue: No ]
    Comparisons of abdominal pain frequency (number of abdominal pain episodes per day) will be made between each two day dietary period spanning a 9 days.


Secondary Outcome Measures:
  • Abdominal pain severity [ Time Frame: 9 days (2 dietary intervention periods) ] [ Designated as safety issue: No ]
    The severity of abdominal pain episodes will be measured on a 1-10 (10 being most severe) ordinal scale. Average severity per abdominal pain episode during each two day dietary period will be compared over 9 days.

  • Hydrogen gas production [ Time Frame: 9 days (2 dietary intervention periods) ] [ Designated as safety issue: No ]
    Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High fermentable substrate diet
High fermentable substrate diet provided for two days
Other: High fermentable substrate diet
Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
Experimental: Low fermentable substrate diet
Low fermentable substrate diet provided for two days
Other: Low fermentable substrate diet
Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.

Detailed Description:

Many children experience stomach pain or discomfort at some point during their lives. Some children have belly discomfort frequently while others rarely have this problem. There have been very few studies to test treatments for recurrent stomach discomfort in children. Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may help. Currently, we do not know if these same diets will work in children with the same problem.

In this study, two different diets will be provided (delivered) for two days with at least 5 days in between each provided diet. The child's symptoms will be recorded over the two days of each diet. Children will be asked to capture samples of their breath during the last day of the each two day delivered diet. Stool samples will also be collected.

  Eligibility

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

Inclusion Criteria:

Must include all of the following:

  1. Children between the ages of 7-17 years;
  2. Meet the criteria for IBS based on the Questionnaire on Pediatric Gastrointestinal Symptoms Rome III Version, including pain/discomfort a minimum of twice per week;
  3. Negative physician evaluation for an organic etiology of the pain within the past year

Exclusion Criteria:

Will include any of the following:

  1. Diabetes or other disease process requiring specialized dietary management;
  2. Malnutrition or obesity (BMI >95%);
  3. Inability to eat by mouth;
  4. Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt);
  5. Neuromodulator (e.g. amitriptyline) usage within the past 3 months
  6. Start of, or change in gastrointestinal medication (e.g. laxative) dose that may cause or ameliorate abdominal 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: NCT01339117

Contacts
Contact: Cynthia Tsai ct2@bcm.edu

Locations
United States, Texas
Children's Nutrition Research Center Recruiting
Houston, Texas, United States, 77030
Contact: Cynthia M Tsai       ct2@bcm.edu   
Principal Investigator: Bruno P Chumpitazi, MD, MPH         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Cynthia Tsai       ct@bcm.edu   
Principal Investigator: Bruno P Chumpitazi, MD, MPH         
Sponsors and Collaborators
Baylor College of Medicine
NASPGHAN Foundation
Investigators
Principal Investigator: Bruno P Chumpitazi, MD, MPH Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Bruno Chumpitazi, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01339117     History of Changes
Other Study ID Numbers: H-28050
Study First Received: April 14, 2011
Last Updated: May 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
irritable bowel syndrome
children
chronic abdominal pain
recurrent abdominal pain

Additional relevant MeSH terms:
Abdominal Pain
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 30, 2014