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Study of Oro-cecal Transit Time in Healthy Subjects Using Scintigraphy and Lactulose Hydrogen Breath Test.

NCT05004207 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-08-13

No results posted yet for this study

Summary

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

Conditions

  • Small Bowel Disease
  • Motility Disorder
  • Irritable Bowel Syndrome

Interventions

DIAGNOSTIC_TEST

99mTc Scintigraphy

After fasting for at least 8 to 12 hours, standardized meal mixed with 99mTc-sulfur colloid radiolabeled test will be administered as quickly as possible, optimally within 10 min. Imaging will be obtained with Siemens SYMBIA E dual head (SPECT) scanner in a format of at least 128 x 128 pixels. Anterior and posterior planar images (or a single left anterior oblique image) with the distal esophagus, stomach, and proximal small bowel in the field of view will be obtained for 1 min immediately after ingestion of the test meal and repeated images will be obtained in the same projections with 2 min static images at hourly intervals up to 6 h and at 24 hours as was used for the initial images. Next day LHBT will be performed after at least 12 hours of fasting. Following administration of test substrate (Lactulose 10 grams) with one cup of water, breath samples will be analyzed for hydrogen every 15 minutes for 1 hour followed by every half hour for next 2 hour with LACTOFEN 2 device.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Rakesh kalapala, MBBS, MD, DM · Senior Consultant

  • Pratik Chhabra, MBBS, MD · Fellow

  • Suneetha B, MBBS, MD, DM · Consultant

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004207 on ClinicalTrials.gov