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View Clinical Trial (Medical Research Study)
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Restricted Fermentable Substrate Diet for Children With Irritable Bowel Syndrome (IBS) - NCT01018498-77030B (Clinical Trial 445298)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy445298.aspx
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Irritable Bowel Syndrome - Fructose Malabsorption |
| Purpose: |
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Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable
bowel syndrome in adults and children. Recently, a diet known as a restricted fermentable
oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet that lowers
intake of a combination of fermentable substrates 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.
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| Study summary: |
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Up to 19% of school-aged children have recurrent abdominal pain (RAP), accounting for 5% of
all pediatric office visits and increased morbidity. The majority of children with RAP have
irritable bowel syndrome (IBS) with up to 60% these children going on to develop IBS as
adults. IBS accounts for up to 8 billion dollars a year of healthcare costs in adults
within the United States. Successful interventions that ameliorate symptoms in childhood
IBS may have an impact into adulthood, however current clinical interventions are often
ineffective.
As in adults, the etiology of childhood IBS is multi-factorial, with food intolerance and
increased gastrointestinal inflammation being potential factors. Another factor, that of
malabsorption of fermentable substrates (e.g., fructose), has frequently been postulated as
a form of food intolerance that exacerbates IBS symptoms in adults and children. Studies
suggest up to 61% of children with RAP have fructose malabsorption. The interactions
between factors such as increased gastrointestinal inflammation and malabsorption of
fermentable substrates and they relate to an individual patient is currently unknown.
Recently, a diet known as a restricted fermentable oligosaccharides, disaccharides,
monosaccharides, and polyols (FODMAPs) diet that lowers intake of a combination of
fermentable substrates has been found to be effective in adults with IBS identified with
fructose malabsorption. This diet has not been used in children with IBS nor has its
mechanism(s) of efficacy been explored. This pilot project focuses on using a restricted
FODMAPs diet as a treatment in children with IBS, while evaluating decreased bacterial
fermentation gas production and decreased gastrointestinal inflammation as mechanisms of its
effect.
Using a prospective, randomized (restricted FODMAPs diet versus regular unrestricted diet),
open label, controlled, 5 week design in children with fructose malabsorption meeting Rome
III childhood IBS criteria, our Specific Aims are to: 1) Characterize the effectiveness of a
restricted FODMAPs diet in improving symptoms (number of abdominal pain episodes, severity
of abdominal pain episodes; primary endpoints); 2) Ascertain whether a restricted FODMAPs
diet decreases GI bacterial fermentation gas production (hydrogen and methane production
measured via lactulose breath testing) and decreases GI inflammation (determined by fecal
calprotectin concentration). We Hypothesize that: 1) A restricted FODMAPs diet will improve
abdominal pain symptoms associated with childhood IBS and identified fructose malabsorption;
2) A restricted FODMAPs diet will improve symptoms in part by decreasing bacterial
fermentation gas production and by decreasing gastrointestinal inflammation.
The results of this proposal may, if applied on a larger scale, aid a large number of
children with IBS and potentially provide insight into the mechanism(s) behind successful
dietary interventions for childhood IBS. Furthermore, findings from this pilot study can be
used toward a developing a larger, randomized, double blind controlled trial that will
investigate in more detail potential mechanisms whereby a restricted FODMAPs diet improves
symptoms in children with IBS. |
| Criteria: |
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Inclusion Criteria:
- Ages 7-12
- Meet criteria for irritable bowel syndrome
- Fructose malabsorption
- Negative physician evaluation within past year for abdominal pain
Exclusion Criteria:
- 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 |
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| Study is available at: |
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Texas Children's Hospital
Houston, TX 77030
United States
Primary Contact:
Kenn Fairly
Email: kfairly@bcm.edu
Phone: 832-824-1383 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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