Trial record 6 of 10 for:    "hereditary fructose intolerance" OR "Fructose Metabolism, Inborn Errors" OR "Fructose Intolerance"

Clinical Utility of Breath Tests in GI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03261856
Recruitment Status : Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
Augusta University

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. We aim to assess the prevalence of SIBO, fructose and lactose intolerance, the usefulness of breath tests, and predictive value of pre-test symptoms.

Condition or disease
Small Intestinal Bacterial Overgrowth Lactose Intolerance Fructose Intolerance Glucose Intolerance

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 life3. 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,4 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 our 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.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Utility of Carbohydrate Breath Tests in Unexplained GI Symptoms
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Primary Outcome Measures :
  1. Small Intestinal Bacterial Overgrowth [ Time Frame: 3 hour test ]
    bacterial overgrowth which results in the inability to absorb nutrients

  2. Positive Breath test [ Time Frame: 3 hour 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. Malabsorption [ Time Frame: 3 hour test ]
    significant rise in hydrogen and/or methane levels

  4. Intolerance [ Time Frame: 3 hour test ]
    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

  5. Normal test [ Time Frame: 3 hour test ]
    absence of GI symptoms or change in symptoms during the test together with no significant increase in the levels of hydrogen and methane.

  6. hypersensitivity [ Time Frame: 3 hour test ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03261856

Contact: Rachael Parr, MPH 7067211968
Contact: Satish Rao, MD, PhD 7067212238

Sponsors and Collaborators
Augusta University
Principal Investigator: Satish Rao, MD, PhD Augusta University

Responsible Party: Augusta University Identifier: NCT03261856     History of Changes
Other Study ID Numbers: 1114725
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Augusta University:
Breath test

Additional relevant MeSH terms:
Fructose Intolerance
Fructose Metabolism, Inborn Errors
Glucose Intolerance
Lactose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn