Small Intestinal Bacterial OvergrowthSIBONCT02872961
SIBO, Immune Activation, and FGIDs in Children
An observational study of Small Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth, Irritable Bowel Syndrome, Functional Dyspepsia
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 13 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients (ages 4-17 years) presenting to the University of Texas-Houston Pediatric GI Clinic with complaints of abdominal pain and undergoing endoscopy (i.e., esophagogastroduodenoscopy [EGD] and possibly colonoscopy) for further evaluation (at the discretion of the patient's gastroenterologist) will be screened for inclusion into the study at the time that the endoscopic evaluation is ordered by the patient's gastroenterologist.
Who may be able to join
- Pediatric patient, aged 4-17 years, upon initial evaluation for abdominal pain.
- Complaints of abdominal pain for at least 2 months upon entry into the study.
- Esophagogastroduodenoscopy (EGD) ordered by the patient's gastroenterologist for further evaluation / work-up of the patient's abdominal pain.
- 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).
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas of Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Small Intestinal Bacterial Overgrowth, Irritable Bowel Syndrome, Functional Dyspepsia, Functional Abdominal Pain
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SIBO Positive | Positive small bowel aspirate culture and/or positive glucose breath test | |
| SIBO Negative | Negative small bowel aspirate culture and negative glucose breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain Index
To further evaluate symptom severity, on the day of endoscopic evaluation, each subject (or the legal guardian, when appropriate) will be asked to complete the Abdominal Pain Index, which is comprised of five items assessing the frequency, duration, and intensity of abdominal pain episodes the subject has experienced during the previous two weeks. This index was previously validated as a clinical measure of abdominal pain in pediatric patients. Responses to the five pain ratings are standardized, and the Z-scores are averaged to yield an index of abdominal pain.
Measured: Baseline
Secondary outcomes (6)
Duodenal fluid microbiota
Small bowel aspirate specimens of 10 patients from each group (20 total samples) will be randomly selected for further analysis. The tubes will be batched, and the preserved samples will be processed (via microbial DNA extraction, followed by bacterial 16S rRNA gene amplification via PCR), after which deep pyrosequencing analysis of the PCR-amplified 16S rRNA genes will be performed. Pyrosequencing data is processed using the Ribosomal Database Project (RDP) pyrosequencing pipeline (http://pyro.cme.msu.edu/). Statistical differences in the diversity and phylogenetic composition of bacteria in the specimens will be assessed by using the online analysis tools at the RDP pyrosequencing pipeline website and by using both the standard and quantitative UniFrac analyses.
Measured: Baseline
Serum biomarker levels
Levels of key circulating gut biomarkers of inflammation will be measured in serum samples; specifically, levels of IL-1-β, IL-6, IL-8, IL-10, IL-12p70, IFN-γ,TNF-α, and osteoprotegerin), intestinal barrier function (TIMP-1), and GI motility (BDNF) will be measured.
Measured: Baseline
Duodenal tissue inflammatory cell infiltration
Mucosal immune cells from duodenal biopsy specimens will be characterized using Giemsa staining for identification of mast cells and antibodies directed against CD4, CD8 (T-cell markers), and CD20 (B-cell marker) using accepted methods for immunohistochemistry. Quantification of immune cells will be performed on both the hematoxylin and eosin (e.g., total immune cells, lymphocytes, monocytes, eosinophils, basophils) and immunohistochemically stained sections (e.g., mast cells, T-lymphocytes, B-lymphocytes).
Measured: Baseline
Duodenal tissue toll-like receptor expression
Small intestinal toll-like receptor expression will be determined via immunohistochemical staining using established protocols. Levels of the following toll-like receptors will be checked: TLR-2, TLR-4, TLR-5, TLR-9 as these toll-like receptors recognize bacterial ligands and are elevated in inflammatory conditions.
Measured: Baseline
Duodenal tissue cytokine levels
The following cytokine levels will be measured in the small intestinal tissue lysate: Human IL-1-β, IL-6, IL-8, IL-10, IL-12p70, IFN-γ, and TNF-α.
Measured: Baseline
Wong-Baker FACES Pain Rating Scale
To further assess the subject's abdominal pain severity, on the day of endoscopic evaluation, each subject (or the legal guardian, when appropriate) will be asked to rate the subject's current pain, average pain over the preceding two weeks, and worst pain experienced during the preceding two weeks using the Wong-Baker FACES™ Pain Rating Scale. This scale has been validated for use in children and consists of faces showing varying degrees of discomfort, along with corresponding descriptions of the pain and numbers to rate pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startApr 2013
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa R Van Arsdall, The University of Texas Health Science Center, Houston
- Investigators
- Melissa R Van Arsdall, MD, Principal investigator, The University of Texas of Health Science Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872961
- Sponsor's protocol ID
- HSC-MS-11-0726
- Acronym
- SIBO
- Status last verified
- Mar 2021
- First submitted
- 9 Jun 2016
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Small Intestinal Bacterial Overgrowth (SIBO) and Immune System Activation in Childhood Abdominal Pain-Related Functional Gastrointestinal Disorders (FGIDs)
- ClinicalTrials.gov ID
- NCT02872961
- Acronym / sponsor ID
- SIBO / HSC-MS-11-0726
- Conditions
- Small Intestinal Bacterial Overgrowth, Irritable Bowel Syndrome, Functional Dyspepsia, Functional Abdominal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIBO Positive | – | –Positive small bowel aspirate culture and/or positive glucose breath test |
| SIBO Negative | – | –Negative small bowel aspirate culture and negative glucose breath test |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients (ages 4-17 years) presenting to the University of Texas-Houston Pediatric GI Clinic with complaints of abdominal pain and undergoing endoscopy (i.e., esophagogastroduodenoscopy [EGD] and possibly colonoscopy) for further evaluation (at the discretion of the patient's gastroenterologist) will be screened for inclusion into the study at the time that the endoscopic evaluation is ordered by the patient's gastroenterologist.
Key inclusion criteria (5 listed)
- Pediatric patient, aged 4-17 years, upon initial evaluation for abdominal pain.
- Complaints of abdominal pain for at least 2 months upon entry into the study.
- Esophagogastroduodenoscopy (EGD) ordered by the patient's gastroenterologist for further evaluation / work-up of the patient's abdominal pain.
- 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).
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Abdominal Pain Index
Time frame: Baseline
To further evaluate symptom severity, on the day of endoscopic evaluation, each subject (or the legal guardian, when appropriate) will be asked to complete the Abdominal Pain Index, which is comprised of five items assessing the frequency, duration, and intensity of abdominal pain episodes the subject has experienced during the previous two weeks. This index was previously validated as a clinical measure of abdominal pain in pediatric patients. Responses to the five pain ratings are standardized, and the Z-scores are averaged to yield an index of abdominal pain.
6 secondary outcomes
Duodenal fluid microbiota
Time frame: Baseline
Serum biomarker levels
Time frame: Baseline
Duodenal tissue inflammatory cell infiltration
Time frame: Baseline
Duodenal tissue toll-like receptor expression
Time frame: Baseline
Duodenal tissue cytokine levels
Time frame: Baseline
Wong-Baker FACES Pain Rating Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa R Van Arsdall, MD principal investigator
The University of Texas of Health Science Center at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Pain Index (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.