AzTrials
AzTrials

Small Intestinal Bacterial OvergrowthNCT03261856

Clinical Utility of Breath Tests in GI

An observational study of Small Intestinal Bacterial Overgrowth and Lactose Intolerance, run by Augusta University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,080 participants
Where
1 siteUnited States
Study dates
31 Aug 2011to 31 Dec 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Augusta University

    Augusta, Georgia, 30912

Other trials in United States

About this study

Official title: Clinical Utility of Carbohydrate Breath Tests in Unexplained GI Symptoms

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.

Keywords
Breath test, SIBO, GI
Medical subject headings
Lactose Intolerance, Fructose Intolerance, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03261856
Study groupRoleWhat they receive
small intetsinal bacterial overgrowthGlucose breath test, 75 g glucose in 250 ml water. Breath samples collected at baseline and every 15 min for 2 hours
Fructose breath TestFructose breath test, 25 g fructose in 250 ml water. Breath samples collected at baseline and every 30 min for 3 hours
Lactose Breath testLactose breath test, 25 g lactose in 250 ml water. Breath samples collected at baseline and every 30 min for 5 hours

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Small Intestinal Bacterial Overgrowth

    bacterial overgrowth which results in the inability to absorb nutrients

    Measured: 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.

    Measured: 3 hour test

  3. Malabsorption

    significant rise in hydrogen and/or methane levels

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 3 hour test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start31 Aug 2011
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

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 only
Time perspective
Retrospective
Enrolment
1,080 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261856
Sponsor's protocol ID
1114725
Status last verified
Jul 2018
First submitted
23 Aug 2017
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Small Intestinal Bacterial Overgrowth and Lactose Intolerance, run by Augusta University 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 4 inclusion and 4 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 17 Feb 2020. 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?

Small Intestinal Bacterial Overgrowth (time frame: 3 hour test). The study lists 6 primary outcomes in all. 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 17 Feb 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in