NCT01018498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2009

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

October 28, 2009

Last Update Submit

January 16, 2018

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeChildren

Outcome Measures

Primary Outcomes (1)

  • Improvement in pain frequency

    Prior to and after 1 week of treatment

Secondary Outcomes (4)

  • Changes in GI Transit Time

    Prior to and after 1 week of treatment

  • Changes in Breath Hydrogen and Methane production

    Prior to and after 1 week of treatment

  • Changes in GI Permeability

    Prior to and after 1 week of treatment

  • Changes in fecal microbiome

    Prior to and after 1 week of treatment

Study Arms (1)

Restricted FODMAPs diet

EXPERIMENTAL

Restricted fermentable substrate diet for 1 week

Behavioral: Restricted FODMAPs diet

Interventions

Restricted FODMAPs dietBEHAVIORAL

Restricted fermentable substrate diet

Restricted FODMAPs diet

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, 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.

    PMID: 24637601RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Bruno P Chumpitazi, M.D., M.P.H.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2009

First Posted

November 23, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(2)