Completed

SIBORelationship Between Small Intestinal Bacterial Overgrowth (SIBO) and Immune System Activation in Childhood Abdominal Pain-Related Functional Gastrointestinal Disorders (FGIDs)

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
DNA Samples
Who is being recruted

Colonic Diseases+3

+ Colonic Diseases, Functional

+ Digestive System Diseases

From 4 to 17 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: April 2013
See protocol details

Summary

Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleRelationship Between Small Intestinal Bacterial Overgrowth (SIBO) and Immune System Activation in Childhood Abdominal Pain-Related Functional Gastrointestinal Disorders (FGIDs)
NCT02872961
Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic Diseases, FunctionalDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesIrritable Bowel Syndrome

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The University of Texas of Health Science Center at Houston

Houston, United StatesOpen The University of Texas of Health Science Center at Houston in Google Maps
CompletedOne Study Center
SIBO | Relationship Between Small Intestinal Bacterial Overgrowth (SIBO) and Immune System Activation in Childhood Abdominal Pain-Related Functional Gastrointestinal Disorders (FGIDs) | PatLynk