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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03720314 -
Microbiota Profiling in IBS
|
||
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT05213910 -
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
|
N/A | |
Recruiting |
NCT05985018 -
Traditional Dietary Advice Vs. Mediterranean Diet in IBS
|
N/A | |
Completed |
NCT04486469 -
Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.
|
N/A | |
Completed |
NCT06407609 -
Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS
|
N/A | |
Completed |
NCT04656730 -
Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
|
Phase 4 | |
Completed |
NCT04145856 -
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
|
Phase 4 | |
Recruiting |
NCT04138225 -
The Ecological Role of Yeasts in the Human Gut
|
||
Active, not recruiting |
NCT03586622 -
One Year Home Monitoring and Treatment of IBS Patients
|
N/A | |
Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
Not yet recruiting |
NCT06369753 -
Visible Abdominal Distension
|
N/A | |
Not yet recruiting |
NCT05157867 -
In Vivo Effects of Amylase Trypsin Inhibitors
|
N/A | |
Not yet recruiting |
NCT05100719 -
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
|
N/A | |
Recruiting |
NCT05001997 -
Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
|
N/A | |
Recruiting |
NCT02953171 -
Probiotics in the Treatment of Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT02977975 -
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT03266068 -
Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
|
||
Completed |
NCT03318614 -
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
|
Phase 2/Phase 3 | |
Completed |
NCT02980406 -
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
|
N/A |