Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restricted FODMAPs diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Children
Eligibility 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
Sites / Locations
- Children's Nutrition Research Center
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Restricted FODMAPs diet
Arm Description
Restricted fermentable substrate diet for 1 week
Outcomes
Primary Outcome Measures
Improvement in pain frequency
Secondary Outcome Measures
Changes in GI Transit Time
Changes in Breath Hydrogen and Methane production
Changes in GI Permeability
Changes in fecal microbiome
Full Information
NCT ID
NCT01018498
First Posted
October 28, 2009
Last Updated
January 16, 2018
Sponsor
Baylor College of Medicine
Collaborators
American College of Gastroenterology, Texas Medical Center Digestive Disease Center, NASPGHAN Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01018498
Brief Title
Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome
Official Title
Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
American College of Gastroenterology, Texas Medical Center Digestive Disease Center, NASPGHAN Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restricted FODMAPs diet
Arm Type
Experimental
Arm Description
Restricted fermentable substrate diet for 1 week
Intervention Type
Behavioral
Intervention Name(s)
Restricted FODMAPs diet
Intervention Description
Restricted fermentable substrate diet
Primary Outcome Measure Information:
Title
Improvement in pain frequency
Time Frame
Prior to and after 1 week of treatment
Secondary Outcome Measure Information:
Title
Changes in GI Transit Time
Time Frame
Prior to and after 1 week of treatment
Title
Changes in Breath Hydrogen and Methane production
Time Frame
Prior to and after 1 week of treatment
Title
Changes in GI Permeability
Time Frame
Prior to and after 1 week of treatment
Title
Changes in fecal microbiome
Time Frame
Prior to and after 1 week of treatment
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno P Chumpitazi, M.D., M.P.H.
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
24637601
Citation
Chumpitazi BP, Hollister EB, Oezguen N, Tsai CM, McMeans AR, Luna RA, Savidge TC, Versalovic J, Shulman RJ. Gut microbiota influences low fermentable substrate diet efficacy in children with irritable bowel syndrome. Gut Microbes. 2014 Mar-Apr;5(2):165-75. doi: 10.4161/gmic.27923. Epub 2014 Jan 27.
Results Reference
result
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