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Completed

NCT Number: NCT01339117

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Nutrition Research Center, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low fermentable substrate diet

Other

Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.

High fermentable substrate diet

Other

Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • NASPGHAN Foundation

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Apr 20, 2011
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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