NCT03261856

Brief Summary

Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative; these patients are labeled as IBS. In these patients, whether testing for carbohydrate malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear. Investigators aim to assess the prevalence of SIBO, fructose and lactose intolerance, the usefulness of breath tests, and predictive value of pre-test symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2011

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 17, 2020

Status Verified

July 1, 2018

Enrollment Period

6.3 years

First QC Date

August 23, 2017

Last Update Submit

February 13, 2020

Conditions

Small Intestinal Bacterial OvergrowthLactose IntoleranceFructose IntoleranceGlucose Intolerance

Keywords

Breath testSIBOGI

Outcome Measures

Primary Outcomes (6)

  • Small Intestinal Bacterial Overgrowth

    bacterial overgrowth which results in the inability to absorb nutrients

    3 hour test

  • Positive Breath test

    significant increase in the level of Hydrogen greater than or equal to 20ppm or methane greater than or equal to 15ppm or both above greater than or equal to 15ppm baseline.

    3 hour test

  • Malabsorption

    significant rise in hydrogen and/or methane levels

    3 hour test

  • Intolerance

    both the presence of malabsorption and the onset of new symptom or an increase (greater than or equal to 1) in the severity of baseline symptoms

    3 hour test

  • Normal test

    absence of GI symptoms or change in symptoms during the test together with no significant increase in the levels of hydrogen and methane.

    3 hour test

  • hypersensitivity

    significant increase (greater than or equal to 1) in the severity of two or more baseline symptoms together with no significant rise in hydrogen or methane levels

    3 hour test

Study Arms (3)

small intetsinal bacterial overgrowth

Glucose breath test, 75 g glucose in 250 ml water. Breath samples collected at baseline and every 15 min for 2 hours

Fructose breath Test

Fructose breath test, 25 g fructose in 250 ml water. Breath samples collected at baseline and every 30 min for 3 hours

Lactose Breath test

Lactose breath test, 25 g lactose in 250 ml water. Breath samples collected at baseline and every 30 min for 5 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have had breath tests as part of routine standard of care to diagnose the unexplained GI symptoms that were abnormal results.

You may qualify if:

  • Patients over the age of 18
  • Unexplained GI symptoms (gas, bloating, diarrhea, fullness, belching, and abdominal pain)
  • Patients who have had normal blood tests and colonoscopy, normal CT or ultrasound scan of the abdomen
  • Patients who have completed at least one breath test

You may not qualify if:

  • Patients with previous GI surgeries (except cholecystectomy, hysterectomy, Nissen funduplication and appendectomy)
  • Significant comorbid medical problems (congestive heart failure, chronic renal failure, respiratory failure)
  • Cancer
  • History of recent antibiotic use (4 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Lactose IntoleranceFructose IntoleranceGlucose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesFructose Metabolism, Inborn ErrorsHyperglycemiaGlucose Metabolism Disorders

Study Officials

  • Satish SC Rao, MD, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

August 31, 2011

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 17, 2020

Record last verified: 2018-07

Locations

US(1)