Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

NCT01339117 | Completed

• 1 other identifier: H-28050
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Keywords

irritable bowel syndrome; children; chronic abdominal pain; recurrent abdominal pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Abdominal pain severity

  9 days (2 dietary intervention periods)

• Hydrogen gas production

  9 days (2 dietary intervention periods)

Study Arms (2)

High fermentable substrate diet

EXPERIMENTAL

High fermentable substrate diet provided for two days

Other: High fermentable substrate diet

Low fermentable substrate diet

EXPERIMENTAL

Low fermentable substrate diet provided for two days

Other: Low fermentable substrate diet

Interventions

Low fermentable substrate diet OTHER

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

Low fermentable substrate diet

High fermentable substrate diet OTHER

Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols

High fermentable substrate diet

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• NASPGHAN Foundation: collaborator

Study Sites (2)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 26104013 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Bruno P Chumpitazi, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 20, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

US (2)