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Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT01339117
Recruitment Status : Unknown
Verified August 2017 by Bruno Chumpitazi, Baylor College of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : April 20, 2011
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
NASPGHAN Foundation
Information provided by (Responsible Party):
Bruno Chumpitazi, Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Abdominal Pain Other: Low fermentable substrate diet Other: High fermentable substrate diet Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Study Start Date : January 2011
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Average daily abdominal pain frequency [ Time Frame: 9 days (2 dietary intervention periods) ]
    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 :
  1. Abdominal pain severity [ Time Frame: 9 days (2 dietary intervention periods) ]
    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.

  2. Hydrogen gas production [ Time Frame: 9 days (2 dietary intervention periods) ]
    Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339117


Locations
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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
NASPGHAN Foundation
Investigators
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Principal Investigator: Bruno P Chumpitazi, MD, MPH Baylor College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bruno Chumpitazi, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01339117    
Other Study ID Numbers: H-28050
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Keywords provided by Bruno Chumpitazi, Baylor College of Medicine:
irritable bowel syndrome
children
chronic abdominal pain
recurrent abdominal pain
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Abdominal Pain
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive