Intestinal Permeability in Children/Adolescents With Functional Dyspepsia - NCT00363597-64108 (Clinical Trial 147582)
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| City: |
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Kansas City |
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State:
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MO |
| Zip Code: |
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64108 |
| Conditions: |
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Functional Dyspepsia |
| Purpose: |
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The main purpose of this study is to evaluate whether intestinal permeability and/or serum
zonulin concentration is increased in children/adolescents with functional dyspepsia (FD).
The study will also explore the relationships between intestinal permeability, mucosal
inflammation and anxiety in FD patients.
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| Study summary: |
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Recurrent abdominal pain is a common complaint among school-age children, being present in
up to 15% at any given time. It represents the most common chronic pain entity in pediatric
patients. The great majority of these patients will have a functional gastrointestinal
disorder (FGID). The most common FGID in these patients is functional dyspepsia (FD),
defined as upper abdominal pain or discomfort unrelieved by bowel movement and in the
absence of a structural or biochemical explanation for the pain. The etiology of FD is
multifactorial, including biological factors, and these factors can be viewed within a
biopsychosocial model. Biological factors include inflammation, dysmotility and increased
visceral sensitivity. These biological factors are influenced by and are interactive with
psychosocial factors such as anxiety, depression and social interaction. This study will
evaluate intestinal permeability as a measure of barrier dysfunction and investigate the
correlations between increased permeability, mucosal inflammation and anxiety scores to
provide further insight into the etiology of FD, thereby assisting in the development and
selection of treatment modalities. |
| Criteria: |
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Inclusion Criteria:
- abdominal pain of at least 8 weeks duration and fulfilling Rome II symptom based
criteria for functional dyspepsia (patient group only);
- undergoing endoscopy to evaluate FD following demonstration of a lack of clinical
response to standard acid reduction therapy (patient group only); and,
- informed permission/assent
Exclusion Criteria:
- previous abdominal surgery;
- any chronic non-gastrointestinal illness requiring regular medical care (e.g.
diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer);
- any history of an adverse reaction to lactulose or mannitol;
- any use of antacids or laxatives within 1 week prior to the study;
- any use of steroids, antihistamines or antihistamine-like drugs within 4 weeks prior
to the study;
- any use of aspirin is prohibited within one week prior to the study;
- any use of non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin is
restricted within one week prior to the study or at the discretion of the Study
Physician;
- any use of antibiotics including neomycin (Mycifradin) within 4 weeks prior to the
study;
- pregnancy;
- any current or chronic history within the previous 6 months of gastrointestinal
symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea
or constipation (healthy control group only); or
- non-English speaking |
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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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February 1, 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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