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Intestinal Dysmotility: Effect of Colonic Load

NCT05046743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-09-29

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

OTHER

Colonic gas load

Colonic infusion of gas via an anal cannula

OTHER

Sham load

Sham infusion of gas via an anal cannula

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • Spain

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 NCT05046743 on ClinicalTrials.gov