SIBO, Immune Activation, and FGIDs in Children
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Pain, Gastroesophageal Reflux Disease , Irritable Bowel Syndrome (IBS), Gastrointestinal, Pain |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 4 - 17 |
| Updated: | 6/1/2018 |
| Start Date: | April 2013 |
| End Date: | October 2018 |
Relationship Between Small Intestinal Bacterial Overgrowth (SIBO) and Immune System Activation in Childhood Abdominal Pain-Related Functional Gastrointestinal Disorders (FGIDs)
PURPOSE: This study will evaluate the relationships between small intestinal bacterial
overgrowth (SIBO), immune activation, inflammation, and symptoms in pediatric abdominal
pain-related functional gastrointestinal disorders (FGIDs), i.e., irritable bowel syndrome
(IBS), functional dyspepsia (FD), & functional abdominal pain (FAP), to better understand the
role of SIBO in their pathogenesis. DESIGN & PROCEDURES: Cross-sectional study. Subjects:
Patients followed at the UT-Houston Pediatric GI clinic, aged 4-17 years, undergoing
endoscopic evaluation of abdominal pain, meeting Rome III diagnostic criteria for IBS, FD, or
FAP, without evidence of an organic etiology of abdominal pain upon routine laboratory,
radiologic, endoscopic, histologic evaluation. Sample Size: At least 30 patients, ≥ 15 with
SIBO (i.e., positive small bowel aspirate culture and/or glucose breath hydrogen test), and
≥15 without SIBO. Sample Materials: Small bowel biopsies and aspirates, serum, breath
samples, symptom questionnaire responses. Measures: 1) Immune activation & inflammation -
measured by serum cytokine levels & small intestinal tissue inflammatory cell infiltration &
cytokine levels. 2) Symptoms - measured by Abdominal Pain Index, Wong-Baker FACES™ Pain
Rating Scale, Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III Version. 3)
Small bowel microbiota analysis - assessed by 454 pyrosequencing. RISKS & POTENTIAL BENEFITS:
Aside from the risks associated with routine endoscopy with biopsies, which would occur even
without study enrollment, the risks associated with serum collection, one extra biopsy
specimen collection, small bowel aspirate collection, completion of pain scales/
questionnaires, and the glucose breath hydrogen test for the purposes of the study are
minimal. POTENTIAL IMPACT: This study should yield valuable information regarding the
relationships between SIBO, immune activation, inflammation, and symptoms in pediatric IBS,
FD, and FAP. Potential biomarkers to support the diagnosis of these FGIDs and novel targets
for therapy, such as immune molecules and previously unrecognized bacterial phylotypes and
species possibly contributing to disease pathogenesis, may be identified. Also, determining
the reliability of the glucose breath hydrogen test vs. small bowel aspirate culture in the
diagnosis of SIBO in this setting may enable the physician to avoid invasive and costly
procedures in the diagnostic work-up of children with these FGIDs.
overgrowth (SIBO), immune activation, inflammation, and symptoms in pediatric abdominal
pain-related functional gastrointestinal disorders (FGIDs), i.e., irritable bowel syndrome
(IBS), functional dyspepsia (FD), & functional abdominal pain (FAP), to better understand the
role of SIBO in their pathogenesis. DESIGN & PROCEDURES: Cross-sectional study. Subjects:
Patients followed at the UT-Houston Pediatric GI clinic, aged 4-17 years, undergoing
endoscopic evaluation of abdominal pain, meeting Rome III diagnostic criteria for IBS, FD, or
FAP, without evidence of an organic etiology of abdominal pain upon routine laboratory,
radiologic, endoscopic, histologic evaluation. Sample Size: At least 30 patients, ≥ 15 with
SIBO (i.e., positive small bowel aspirate culture and/or glucose breath hydrogen test), and
≥15 without SIBO. Sample Materials: Small bowel biopsies and aspirates, serum, breath
samples, symptom questionnaire responses. Measures: 1) Immune activation & inflammation -
measured by serum cytokine levels & small intestinal tissue inflammatory cell infiltration &
cytokine levels. 2) Symptoms - measured by Abdominal Pain Index, Wong-Baker FACES™ Pain
Rating Scale, Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III Version. 3)
Small bowel microbiota analysis - assessed by 454 pyrosequencing. RISKS & POTENTIAL BENEFITS:
Aside from the risks associated with routine endoscopy with biopsies, which would occur even
without study enrollment, the risks associated with serum collection, one extra biopsy
specimen collection, small bowel aspirate collection, completion of pain scales/
questionnaires, and the glucose breath hydrogen test for the purposes of the study are
minimal. POTENTIAL IMPACT: This study should yield valuable information regarding the
relationships between SIBO, immune activation, inflammation, and symptoms in pediatric IBS,
FD, and FAP. Potential biomarkers to support the diagnosis of these FGIDs and novel targets
for therapy, such as immune molecules and previously unrecognized bacterial phylotypes and
species possibly contributing to disease pathogenesis, may be identified. Also, determining
the reliability of the glucose breath hydrogen test vs. small bowel aspirate culture in the
diagnosis of SIBO in this setting may enable the physician to avoid invasive and costly
procedures in the diagnostic work-up of children with these FGIDs.
Inclusion Criteria:
1. Pediatric patient, aged 4-17 years, upon initial evaluation for abdominal pain.
2. Complaints of abdominal pain for at least 2 months upon entry into the study.
3. Esophagogastroduodenoscopy (EGD) ordered by the patient's gastroenterologist for
further evaluation / work-up of the patient's abdominal pain.
4. Fulfillment of Rome III criteria for the child/adolescent abdominal pain-related
functional gastrointestinal disorders under study (i.e., irritable bowel syndrome,
functional dyspepsia, and functional abdominal pain).
5. Signed informed consent for the subject's participation in the study provided by the
parent / legal guardian; signed assent signed by study participants 8 years and older.
Exclusion Criteria:
History of short bowel syndrome, defined as clinically significant malabsorption resulting
from surgical resection of a substantial portion (≥ 50%) of small intestine, or from
complete dysfunction of an extensive portion (≥ 50%) of small bowel. 2. History of other
gastrointestinal surgery (except for appendectomy). 3. Other known or suspected motility
disorder such as achalasia, gastroparesis, chronic intestinal pseudo-obstruction, dumping
syndrome, Hirschprung's disease, or neuromuscular disease.
4. Evidence of enteric infection or infestation on laboratory screening or on mucosal
biopsy.
5. Known or suspected of liver, renal, or pancreatic disease. 6. Diabetes mellitus,
systemic lupus erythematosus, and/or other systemic disease.
7. Use of antibiotics, mast cell stabilizers, leukotriene modifiers, and/or systemic
steroids within 2 weeks preceding the small bowel aspirate culture and biopsies; use of
antibiotics or probiotics within 2 weeks of the glucose breath hydrogen test.
8. Use of opiates or benzodiazepines (aside from any given for anesthesia purposes for the
endoscopy procedure) or laxatives (aside from any given for bowel preparation for the
endoscopy procedure) within 1 week preceding the small bowel aspirate culture and/ or
glucose breath hydrogen test.
9. Acute infection or other acute inflammatory process (e.g., upper respiratory tract
infection, pneumonia, urinary tract infection, gastroenteritis, pancreatitis, etc.) within
the 2 weeks preceding the serum sample and mucosal biopsy collection.
10. Symptomatic from an atopic disorder (i.e., eczema, allergic rhinitis, asthma) within
the 2 weeks preceding serum collection for the study.
11. Any evidence of inflammatory bowel disease, celiac disease, H. pylori infection,
eosinophilic esophagitis, giardiasis, or other potential organic etiology of abdominal pain
upon endoscopic / histologic evaluation.
12. Cancellation of the endoscopy procedure by the subject's gastroenterologist, parent,
and/ or legal guardian.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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