Small Intestine Bacterial OvergrowthNOVELNCT02745327
Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings
An observational study of Small Intestine Bacterial Overgrowth, run by University of Virginia at 1 site in Bangladesh.
Trial summary
The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Small Intestine Bacterial Overgrowth
- How many people
- 270 participants
- Where
- 1 siteBangladesh
- Study dates
- Nov 2014to Dec 2018
- 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 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Bangladeshi infants from the low-income neighborhood of Mirpur, Dhaka
Who may be able to join
- Child previously enrolled in the FIELD STUDIES protocol (enrollments in both studies may occur simultaneously)
- Mother willing to sign informed consent form.
- Healthy infant aged less than 7 days old
Who cannot join
- Parents are not willing to have child's blood drawn, oral fluid collected, urine collected, or breath testing performed.
- History of seizures, other apparent neurologic disorders, or other congenital abnormalities involving major organ systems.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
The International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.
- Conditions
- Small Intestine Bacterial Overgrowth
- Keywords
- oral vaccination, nutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose-Hydrogen Breath Test
Test for Small Intestine Bacterial Overgrowth
Measured: Birth to 2 years
Secondary outcomes (14)
Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)
Measured: Birth to 2 years
Fecal Myeloperoxidase
Measured: Birth to 2 years
Serum 25-OH vitamin D
Measured: Birth to 2 years
Serum Zinc
Measured: Birth to 2 years
Serum Retinol Binding Protein
Measured: Birth to 2 years
Serum Cobalamin
Measured: Birth to 2 years
Serum Albumin
Measured: Birth to 2 years
Lactulose mannitol ratio
Measured: 12 weeks of age
Serum Tetanus antibody titers
Measured: Birth to 2 years
Serum Polio antibody titers to sabin strains
Measured: Birth to 2 years
Oral fluid Tetanus antibody titers
Measured: Birth to 2 years
Height
Measured: Birth to 2 years
Weight
Measured: Birth to 2 years
Head circumference
Measured: Birth to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Intestine Bacterial OvergrowthStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, William Petri, MD, University of Virginia
- Investigators
- William A Petri, M.D., PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745327
- Sponsor's protocol ID
- PR14083
- Acronym
- NOVEL
- Status last verified
- May 2019
- First submitted
- 15 Apr 2016
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Donowitz JR, Pu Z, Lin Y, Alam M, Ferdous T, Shama T, Taniuchi M, Islam MO, Kabir M, Nayak U, Faruque ASG, Haque R, Ma JZ, Petri WA Jr. Small Intestine Bacterial Overgrowth in Bangladeshi Infants Is Associated With Growth Stunting in a Longitudinal Cohort. Am J Gastroenterol. 2022 Jan 1;117(1):167-175. doi: 10.14309/ajg.0000000000001535.
PubMed 34693912
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition
- ClinicalTrials.gov ID
- NCT02745327
- Acronym / sponsor ID
- NOVEL / PR14083
- Conditions
- Small Intestine Bacterial Overgrowth
- Keywords
- oral vaccination, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Nov 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Apr 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.
The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Bangladeshi infants from the low-income neighborhood of Mirpur, Dhaka
Key inclusion criteria (3 listed)
- Child previously enrolled in the FIELD STUDIES protocol (enrollments in both studies may occur simultaneously)
- Mother willing to sign informed consent form.
- Healthy infant aged less than 7 days old
Key exclusion criteria (2 listed)
- Parents are not willing to have child's blood drawn, oral fluid collected, urine collected, or breath testing performed.
- History of seizures, other apparent neurologic disorders, or other congenital abnormalities involving major organ systems.
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
Glucose-Hydrogen Breath Test
Time frame: Birth to 2 years
Test for Small Intestine Bacterial Overgrowth
14 secondary outcomes
Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)
Time frame: Birth to 2 years
Fecal Myeloperoxidase
Time frame: Birth to 2 years
Serum 25-OH vitamin D
Time frame: Birth to 2 years
Serum Zinc
Time frame: Birth to 2 years
Serum Retinol Binding Protein
Time frame: Birth to 2 years
Serum Cobalamin
Time frame: Birth to 2 years
Serum Albumin
Time frame: Birth to 2 years
Lactulose mannitol ratio
Time frame: 12 weeks of age
Serum Tetanus antibody titers
Time frame: Birth to 2 years
Serum Polio antibody titers to sabin strains
Time frame: Birth to 2 years
Oral fluid Tetanus antibody titers
Time frame: Birth to 2 years
Height
Time frame: Birth to 2 years
Weight
Time frame: Birth to 2 years
Head circumference
Time frame: Birth to 2 years
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 15 May 2019.
- Derived from this study: PubMed 34693912Donowitz JR, Pu Z, Lin Y, Alam M, Ferdous T, Shama T, Taniuchi M, Islam MO, Kabir M, Nayak U, Faruque ASG, Haque R, Ma JZ, Petri WA Jr. Small Intestine Bacterial Overgrowth in Bangladeshi Infants Is Associated With Growth Stunting in a Longitudinal Cohort. Am J Gastroenterol. 2022 Jan 1;117(1):167-175. doi: 10.14309/ajg.0000000000001535.
- Individual participant dataSharing planned: No
Related trials for Small Intestine Bacterial Overgrowth
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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.
William A Petri, M.D., PhD principal investigator
University of Virginia
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 Intestine Bacterial Overgrowth, run by University of Virginia at 1 site in Bangladesh.
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 3 inclusion and 2 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 15 May 2019. 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 Bangladesh. 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?
Glucose-Hydrogen Breath Test (time frame: Birth to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745327, which also lists 1 linked publication.
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 15 May 2019.