Irritable Bowel Syndrome Clinical Trial
Official title:
Oro-cecal Transit Time in Healthy Indian Subjects Using Scintigraphy and Its Correlation With Lactulose Hydrogen Breath Test- A Pilot Study
Radionuclide scintigraphy is the gold standard technique to interpret OCTT but there is no normative data available for its interpretation in Indian population. Previous studies to determine OCTT have all been done with LHBT, which has many limitations. Besides there are few small comparative studies between scintigraphy and LHBT, that too not in Indian population. The aim of this study is to validate LHBT to measure OCTT compared with scintigraphy and to standardize the normal OCTT in healthy individuals
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: • Healthy individual > 18 years of age with no comorbidities Exclusion Criteria: - Thoracic or digestive foregut surgery, - Alcohol consumption >40 g/day, - Use of medications that alter intragastric acidity or oesophageal motility - History of diabetes mellitus, thyroid disorder - Neurological disorders - Chronic gastrointestinal disease - Any subject with upper GI symptoms like pain, burning, belching, bloating, dysphagia & aerophagia |
Country | Name | City | State |
---|---|---|---|
India | AIG Hospitals | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Gilmore IT. Orocaecal transit time in health and disease. Gut. 1990 Mar;31(3):250-1. Review. — View Citation
Miller MA, Parkman HP, Urbain JL, Brown KL, Donahue DJ, Knight LC, Maurer AH, Fisher RS. Comparison of scintigraphy and lactulose breath hydrogen test for assessment of orocecal transit: lactulose accelerates small bowel transit. Dig Dis Sci. 1997 Jan;42( — View Citation
Ning Y, Lou C, Huang Z, Chen D, Huang H, Chen L, Zhang B, Dai N, Zhao J, Zhen X. Clinical value of radionuclide small intestine transit time measurement combined with lactulose hydrogen breath test for the diagnosis of bacterial overgrowth in irritable bo — View Citation
Yu D, Cheeseman F, Vanner S. Combined oro-caecal scintigraphy and lactulose hydrogen breath testing demonstrate that breath testing detects oro-caecal transit, not small intestinal bacterial overgrowth in patients with IBS. Gut. 2011 Mar;60(3):334-40. doi — View Citation
Zhao J, Zheng X, Chu H, Zhao J, Cong Y, Fried M, Fox M, Dai N. A study of the methodological and clinical validity of the combined lactulose hydrogen breath test with scintigraphic oro-cecal transit test for diagnosing small intestinal bacterial overgrowt — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oro-caecal transit time (OCTT) using lactulose hydrogen breath test (LHBT) and scintigraphy study. | LHBT is the commonly used test for OCTT, but it has fallacies, since it itself increase intestinal motility, so this study aims to validate LHBT with scintigraphy which is the gold standard test. | six months | |
Secondary | Normative data for OCTT using nuclear scintigraphy in healthy indian population. | There is no reference values for nuclear scintigraphy in healthy indian patients. The study will help generate data to give reference values for OCTT using scintigraphy. | six months |
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