Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339117
• Other study ID #: H-28050
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2017

Study information

• Verified date: January 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Low fermentable substrate diet
Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.
• High fermentable substrate diet
Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	NASPGHAN Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 days (2 dietary intervention periods)
Secondary	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.	9 days (2 dietary intervention periods)
Secondary	Hydrogen gas production	Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.	9 days (2 dietary intervention periods)