Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy

NCT03662113 | Completed

• 1 other identifier: DomperidoneVCE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.

Conditions

Capsule Endoscopy; Pediatric Disorder

Keywords

domperidone

Outcome Measures

Primary Outcomes (1)

• Completion rate of capsule endoscopy

  CE was considered complete when the cecum was reached within recording time.

  assessed through study completion, an average of 1 year

Secondary Outcomes (2)

• Gastric transit time (GTT)

  assessed through study completion, an average of 1 year

• small bowel transit time (SBTT)

  assessed through study completion, an average of 1 year

Study Arms (2)

Experimental: Domperidone

EXPERIMENTAL

5ml domperidone prior to VCE

Drug: Domperidone

Control: water

OTHER

5ml warm water prior to VCE

Dietary Supplement: water

Interventions

Domperidone DRUG

5ml Domperidone prior to VCE

Also known as: simethicone

Experimental: Domperidone

water DIETARY_SUPPLEMENT

5ml water prior to VCE

Also known as: simethicone

Control: water

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Indications of capsule endoscopy;
• Informed consent form obtained.

You may not qualify if:

• Contraindication of capsule endoscopy;
• Domperidone allergy;
• Unwilling to participate.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (2)

• Mcfarlane M, Liu B, Nwokolo C. Domperidone prolongs oral to duodenal transit time in video capsule endoscopy. Eur J Clin Pharmacol. 2018 Apr;74(4):521-524. doi: 10.1007/s00228-017-2399-8. Epub 2017 Dec 8.

  PMID: 29222714 BACKGROUND

• Wu J, Ye Z, Xue A, Huang Y. Can domperidone decrease transit time of pediatric video capsule endoscopy? A randomized controlled trial. Transl Pediatr. 2021 Feb;10(2):344-349. doi: 10.21037/tp-20-273.

  PMID: 33708520 DERIVED

MeSH Terms

Interventions

Domperidone; Simethicone; Water

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Ying Huang, doctor

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of gastroenterology of Children's Hospital of Fudan University

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)