NCT03266068|Completed
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Sponsor study identifier
Secondary identifiers
observational
120
1 country
1
Study Start
September 2016
Actual (reported)Primary Completion
March 11, 2020
Actual (reported)Study Completion
March 11, 2020
Actual (reported)Some people develop chronic abdominal pain with diarrhea or constipation after an episode of acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact reason why certain individuals develop these symptoms whereas others don't is not exactly clear. The researchers are studying changes in gastrointestinal permeability (movement of contents across the lining of the intestine) and transit (movement of food through the gastrointestinal tract). The researchers are also studying if there are any genetic risk factors that are associated with development of this disorder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 11, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2016
Actual (reported)July 5, 2017
Actual (reported)August 29, 2017
Actual (reported)March 11, 2020
Actual (reported)March 11, 2020
Actual (reported)Colonic geometric center at 24 hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
24 hours
Subjects who have suffered from acute bacterial gastroenteritis within last two years and have developed some symptoms that might be suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.
Subjects who have suffered from acute bacterial gastroenteritis within last two years and have not developed symptoms suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.
DNA analysis of the genes possibly involved in IBS.
Endoscopy of the subject's lower colon in which biopsies of the lining of the colon will be taken.
Post Infectious IBS Cases Post Infectious with no IBS Controls Healthy Volunteer Controls
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Blood, stool, and tissue samples
Madhusudan Grover, MBBS
Mayo Clinic
120 participants (actual enrollment reported by the registry).
First Submitted
July 5, 2017
First Posted
August 29, 2017
Study Start
September 2016
Actual (reported)Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome
Healthy volunteers; subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.
A validated scintigraphic method to measure gastric, small bowel and colonic transit will be used.
Stool samples will be used to extract supernatants. These supernatants will be studied in using chamber set-up to determine barrier effects on T84 monolayers.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 11, 2020
Actual (reported)Study Completion
March 11, 2020
Actual (reported)Last Updated
January 20, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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