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Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339117
First Posted: April 20, 2011
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NASPGHAN Foundation
Information provided by (Responsible Party):
Bruno Chumpitazi, Baylor College of Medicine
April 14, 2011
April 20, 2011
August 2, 2017
January 2011
December 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01339117 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Abdominal Pain
  • Other: Low fermentable substrate diet
    Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.
  • Other: High fermentable substrate diet
    Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
  • Experimental: High fermentable substrate diet
    High fermentable substrate diet provided for two days
    Intervention: Other: High fermentable substrate diet
  • Experimental: Low fermentable substrate diet
    Low fermentable substrate diet provided for two days
    Intervention: Other: Low fermentable substrate diet
Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2017
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01339117
H-28050
No
Not Provided
Not Provided
Bruno Chumpitazi, Baylor College of Medicine
Baylor College of Medicine
NASPGHAN Foundation
Principal Investigator: Bruno P Chumpitazi, MD, MPH Baylor College of Medicine
Baylor College of Medicine
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP