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NCT05046743 Clinical Trial

Intestinal Dysmotility: Effect of Colonic Load

Healthy Volunteers Clinical Trial

Official title:
Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05046743
Other study ID # PR(AG)56/2018B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date May 30, 2021

Study information
Verified date September 2021
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Abnormal motility patterns in the jejunum can be detected in patients with prominent colonic distension, and it is not clear whether these abnormalities reflect a primary jejunal dysfunction or are due to a reflex distortion. The aim of the study is to determine the effect of colonic filling on jejunal postprandial motility using high-resolution manometry. Healthy subjects will be studied following a controlled, parallel, randomized, single-blind experimental design. On the study day, nutrients will be continuously infused in the proximal jejunum (2 Kcal/min) during a 2-h period to induce a steady-state postprandial motor pattern. Jejunal motility will be concomitantly recorded using a water-perfused, high-resolution manometry catheter. After 1 hour of postprandial recording (basal period), a gas mixture will be infused during 7.5 minutes via a rectal tube (720 mL or sham infusion), and jejunal motility will be recorded for another hour.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - No digestive symptoms Exclusion Criteria: - Organic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Colonic gas load
Colonic infusion of gas via an anal cannula
• Sham load
Sham infusion of gas via an anal cannula

Locations
Country Name City State
Spain Hospital Vall d'Hebron Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Small bowel contractility Number of contractions 10 minutes
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