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Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome, Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low fermentable substrate diet
High fermentable substrate diet
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring irritable bowel syndrome, children, chronic abdominal pain, recurrent abdominal pain

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Nutrition Research Center
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High fermentable substrate diet

Low fermentable substrate diet

Arm Description

High fermentable substrate diet provided for two days

Low fermentable substrate diet provided for two days

Outcomes

Primary Outcome Measures

Average daily abdominal pain frequency
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
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
Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.

Full Information

First Posted
April 14, 2011
Last Updated
January 20, 2021
Sponsor
Baylor College of Medicine
Collaborators
NASPGHAN Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01339117
Brief Title
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Official Title
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
NASPGHAN Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Abdominal Pain
Keywords
irritable bowel syndrome, children, chronic abdominal pain, recurrent abdominal pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High fermentable substrate diet
Arm Type
Experimental
Arm Description
High fermentable substrate diet provided for two days
Arm Title
Low fermentable substrate diet
Arm Type
Experimental
Arm Description
Low fermentable substrate diet provided for two days
Intervention Type
Other
Intervention Name(s)
Low fermentable substrate diet
Intervention Description
Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.
Intervention Type
Other
Intervention Name(s)
High fermentable substrate diet
Intervention Description
Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
Primary Outcome Measure Information:
Title
Average daily abdominal pain frequency
Description
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.
Time Frame
9 days (2 dietary intervention periods)
Secondary Outcome Measure Information:
Title
Abdominal pain severity
Description
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.
Time Frame
9 days (2 dietary intervention periods)
Title
Hydrogen gas production
Description
Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.
Time Frame
9 days (2 dietary intervention periods)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must include all of the following: Children between the ages of 7-17 years; 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; Negative physician evaluation for an organic etiology of the pain within the past year Exclusion Criteria: Will include any of the following: Diabetes or other disease process requiring specialized dietary management; Malnutrition or obesity (BMI >95%); Inability to eat by mouth; Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt); Neuromodulator (e.g. amitriptyline) usage within the past 3 months Start of, or change in gastrointestinal medication (e.g. laxative) dose that may cause or ameliorate abdominal symptoms within the past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno P Chumpitazi, MD, MPH
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Nutrition Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26104013
Citation
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.
Results Reference
derived

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Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

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