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

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ClinicalTrials.gov Identifier: NCT05004207
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Rakesh Kalapala, Asian Institute of Gastroenterology, India

Brief 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

Condition or disease Intervention/treatment
Small Bowel Disease Motility Disorder Irritable Bowel Syndrome Diagnostic Test: 99mTc Scintigraphy

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oro-cecal Transit Time in Healthy Indian Subjects Using Scintigraphy and Its Correlation With Lactulose Hydrogen Breath Test- A Pilot Study
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans
Drug Information available for: Lactulose


Intervention Details:
  • 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.

    Other Name: Lactulose Hydrogen Breath test


Primary Outcome Measures :
  1. Oro-caecal transit time (OCTT) using lactulose hydrogen breath test (LHBT) and scintigraphy study. [ Time Frame: six months ]
    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.


Secondary Outcome Measures :
  1. Normative data for OCTT using nuclear scintigraphy in healthy indian population. [ Time Frame: six months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy individual > 18 years of age with no comorbidities
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT05004207


Contacts
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Contact: Neeraj Singla, MBBS, MD, DM 7888619216 ext 91 dr.neerajsingla@gmail.com
Contact: Aniruddha P Singh, MBBS, MD, DM 9004093248 ext 91 draniruddhapratapsingh@gmail.com

Locations
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India
AIG Hospitals Recruiting
Hyderabad, Telangana, India, 500032
Contact: Aniruddha P Singh, MBBS,MD,DM    09004093248    draniruddhapratapsingh@gmail.com   
Contact: Neeraj Singla, MBBS,MD,DM    07888619216    dr.neerajsingla@gmail.com   
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Study Director: Rakesh kalapala, MBBS, MD, DM Senior Consultant
Principal Investigator: Pratik Chhabra, MBBS, MD Fellow
Principal Investigator: Suneetha B, MBBS, MD, DM Consultant
Publications of Results:
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Responsible Party: Rakesh Kalapala, Senior Consultant, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT05004207    
Other Study ID Numbers: AIG/IEC-BH&R 15/06.2021-02
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rakesh Kalapala, Asian Institute of Gastroenterology, India:
Small bowel disease
Orocaecal transit time
nuclear scintigraphy
lactulose hydrogen breath test
Additional relevant MeSH terms:
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Intestinal Diseases
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Lactulose
Gastrointestinal Agents