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

NCT05004207 | Unknown DMC

• 1 other identifier: AIG/IEC-BH&R 15/06.2021-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Small Bowel Disease; Motility Disorder; Irritable Bowel Syndrome

Keywords

Small bowel disease; Orocaecal transit time; nuclear scintigraphy; lactulose hydrogen breath test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Normative data for OCTT using nuclear scintigraphy in healthy indian population.

  six months

Interventions

99mTc Scintigraphy DIAGNOSTIC_TEST

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.

Also known as: Lactulose Hydrogen Breath test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy individual \> 18 years of age with no comorbidities

You may qualify if:

• Healthy individual \> 18 years of age with no comorbidities

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (5)

• 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(1):10-8. doi: 10.1023/a:1018864400566.

  PMID: 9009110 RESULT

• 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: 10.1136/gut.2009.205476. Epub 2010 Nov 26.

  PMID: 21112950 RESULT

• 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 bowel syndrome. Hell J Nucl Med. 2016 May-Aug;19(2):124-9. doi: 10.1967/s002449910365. Epub 2016 Jun 22.

  PMID: 27331205 RESULT

• 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 overgrowth in IBS patients. Neurogastroenterol Motil. 2014 Jun;26(6):794-802. doi: 10.1111/nmo.12331. Epub 2014 Mar 18.

  PMID: 24641100 RESULT

• Gilmore IT. Orocaecal transit time in health and disease. Gut. 1990 Mar;31(3):250-1. doi: 10.1136/gut.31.3.250. No abstract available.

  PMID: 2182399 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Rakesh kalapala, MBBS, MD, DM

  Senior Consultant

  STUDY DIRECTOR

• Pratik Chhabra, MBBS, MD

  Fellow

  PRINCIPAL INVESTIGATOR

• Suneetha B, MBBS, MD, DM

  Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeraj Singla, MBBS, MD, DM

CONTACT

7888619216; dr.neerajsingla@gmail.com

Aniruddha P Singh, MBBS, MD, DM

CONTACT

9004093248; draniruddhapratapsingh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 13, 2021
• Study Start: July 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)