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Treatment of Constipation in Functional Dyspepsia

NCT02956187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-19

No results posted yet for this study

Summary

Background. Functional dyspepsia is characterized by symptoms that apparently originate in the stomach without detectable cause by conventional diagnosis test. The pathophysiology of functional dyspepsia is not known, but a number of data indicate that dyspeptic patients have increased sensitivity of the digestive system, so that physiological stimuli may induce their symptoms. Some patients with functional dyspepsia have also functional constipation and the investigators hypothesize that in them constipation triggers or facilitates dyspeptic symptoms, and consequently, correction of constipation relieves dyspeptic symptoms.

Objective. To demonstrate the superiority of biofeedback versus a fiber supplement for the treatment of dyspeptic symptoms in patients with constipation due to functional outlet obstruction.

Design. Randomized, controlled parallel trial performed in a referral center. Participants. Consecutive patients complaining of symptoms of functional dyspepsia and functional outlet obstruction.

Interventions: Patients will be assigned to experimental (biofeedback for functional outlet obstruction) and active comparator (fiber supplementation) arms. Biofeedback for functional outlet obstruction: sessions of biofeedback guided by anorectal manometry (performed during the first 3 weeks of the intervention period) combined with instructions for daily exercising for 4 weeks. Fiber supplementation: 2.5 g plantago ovata per day for 4 weeks. Main outcome and measures. Clinical symptoms of functional dyspepsia measured by daily questionnaires for 7 consecutive days before and during the last week of intervention.

Relevance. Functional Dyspepsia, defined by purely clinical criteria, brings together a diverse group of conditions with different pathophysiology. As a result, the treatment is empirical and globally inefficient. This study will identify a subset of patients with a common pathophysiological mechanism of dyspeptic symptoms (functional outlet obstruction) which respond to specific treatment (biofeedback).

Conditions

Interventions

BEHAVIORAL

Biofeedback

Functional outlet obstruction will be treated by biofeedback: sessions of biofeedback guided by anorectal manometry combined with instructions for daily exercizing for 4 weeks.

DIETARY_SUPPLEMENT

Fiber supplement

3.5 g plantago ovata per day will be administered for 4 weeks.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Fernando Azpiroz, MD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-12
Primary Completion
2017-12-10
Completion
2018-01-08

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT02956187 on ClinicalTrials.gov