ClinicalTrials.gg
CompletedNCT03261856Updated Feb 17, 2020

Clinical Utility of Breath Tests in GI

An observational study in Small Intestinal Bacterial Overgrowth, Lactose Intolerance and Fructose Intolerance, sponsored by Augusta University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Augusta University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,080
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Abdominal bloating, gas, belching, distension, and diarrhea are common gastrointestinal symptoms that are reported by at least 1/3rd of patients presenting to gastroenterology clinics. When routine endoscopic and radiological tests are negative1, most of these patients are labeled as irritable bowel syndrome (IBS) in gastroenterology practice2. Unfortunately these symptoms persist and these patients remain dissatisfied with their health care and continue to doctor shops or seek remedies from alternative care. Several studies have shown that these symptoms have a significant and negative impact on their quality of life. One possible explanation for their symptom is carbohydrate food intolerance. The Western diet has changed significantly over the last 3 decades. Today, large amounts of fructose are being consumed. This sugar is used as a sweetener in sodas, fruit juices, multiples beverages and candies. Although is naturally present in apples, peaches, pears and oranges, the exponential products and consumption of the synthetic high fructose corn syrup has alarmingly increased fructose consumption. When small amounts are ingested, fructose is completely absorbed from the gut mainly through Glut 5transporter from the intestinal brush border or through facilitated transport along glucose through the Glut 2 transporter5. If a person has either limited absorptive capacity or overwhelms normal absorption capacity by excess ingestion, then malabsorption of fructose ensues. This unabsorbed fructose can serve, as an osmotic load, that draws fluid into the intestinal lumen, causing abdominal bloating, gas, pain and diarrhea 6-7. Likewise lactose is a disaccharide that is present in dairy products and is widely consumed. After ingestion lactose is hydrolyzed in the small intestine by the brush border enzyme lactase into glucose and galactose that are in torn absorbed8. If lactose is malabsorbed by Glut 2, then it will serve as an osmotic load, and get rapidly propelled in to the colon where it is fermented by the colonic bacterial flora, into short chain fatty acid, hydrogen,methane and other gases, this lactose malabsorption produces gas, bloating, flatulence and diarrhea9. About 75% of the world´s population gradually lose their ability to produce the lactase enzyme after age 30 years10-11.

Malabsorption or intolerance of carbohydrates such as fructose and lactose are common and frequently encountered both in the primary care and specialist gastroenterology clinics, but are poorly recognized or treated. Over the last decade, breath testing has emerged as a simple, non invasive method of identifying malabsorption and/ or intolerance to common food ingredients such as fructose12, and lactose13, as well as to identify small intestinal bacterial overgrowth (SIBO)14. However, they are only performed in selected academic centers, and their clinical utility and diagnostic yield largely remains unknown.

Also may the clinical utility of performing a single breath test versus a cumulative battery of breath tests, such as glucose, lactose or fructose breath test, in a patient with unexplained GI symptoms is also not known.

The aims of this study are to investigate a consecutive series of patients with unexplained chronic GI symptoms and examine; 1) the prevalence of SIBO answered by the glucose breath test, fructose and lactose intolerance answered by the fructose y lactose breath test, ; 2) the predictive value of pre-test symptoms in the diagnosis of SIBO or carbohydrate intolerance.

02

Conditions studied

  • Small Intestinal Bacterial Overgrowth
  • Lactose Intolerance
  • Fructose Intolerance
  • Glucose Intolerance

Keywords

  • Breath test
  • SIBO
  • GI
03

In context

Lactose Intolerance

53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.

This study's enrollment of 1,080 is above the median of 70 across 11 observational studies indexed under Lactose Intolerance.

Browse Lactose Intolerance studies →

Lead sponsor

Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,080 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Small Intestinal Bacterial Overgrowth

    bacterial overgrowth which results in the inability to absorb nutrients

    Time frame: 3 hour test

  2. 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.

    Time frame: 3 hour test

  3. Malabsorption

    significant rise in hydrogen and/or methane levels

    Time frame: 3 hour test

  4. 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

    Time frame: 3 hour test

  5. 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.

    Time frame: 3 hour test

  6. 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

    Time frame: 3 hour test

07

Study locations

1 site
  • Augusta University
    Augusta, Georgia 30912, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03261856
Lead sponsor
Augusta University
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Aug 31, 2011
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Feb 17, 2020

Study contacts

Satish SC Rao, MD, PhD
principal investigator · Augusta University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion