Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT01018498

Run by

Baylor College of Medicine

People needed

12

Starts

2009-10-01

Expected to finish

2011-09-01

Last updated by the study team

2018-01-18

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 7-17 years
• Meet criteria for Rome III irritable bowel syndrome
• Negative physician evaluation within past year for abdominal pain

You may not qualify if…

• 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

Where it is running

• Children's Nutrition Research Center — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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