Intestinal Dysmotility: Effect of Colonic Load

NCT ID: NCT05046743

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Colonic gas load

Group Type EXPERIMENTAL

Colonic gas load

Intervention Type OTHER

Colonic infusion of gas via an anal cannula

Sham

Group Type SHAM_COMPARATOR

Sham load

Intervention Type OTHER

Sham infusion of gas via an anal cannula

Interventions

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Colonic gas load

Colonic infusion of gas via an anal cannula

Intervention Type OTHER

Sham load

Sham infusion of gas via an anal cannula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* No digestive symptoms

Exclusion Criteria

* Organic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PR(AG)56/2018B

Identifier Type: -

Identifier Source: org_study_id

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