NCT02956187

Treatment of Constipation in Functional Dyspepsia

Completed NA Last updated 19 January 2018

What this trial tests

NA trial testing Biofeedback in Dyspepsia in 40 participants. Completed in 8 January 2018.

Timeline

12 June 2016

Primary endpoint
10 December 2017

8 January 2018

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	12 June 2016
Primary completion	10 December 2017
Estimated completion	8 January 2018
Sites	1 location across Spain

Drugs / interventions tested

• Biofeedback
• Fiber supplement

Conditions studied

• Dyspepsia — all drugs for Dyspepsia →
• Constipation — all drugs for Constipation →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

Adults 18 to 80, any sex, with Dyspepsia or Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Correction of Dyssynergic Defecation, but Not Fiber Supplementation, Reduces Symptoms of Functional Dyspepsia in Patients With Constipation in a Randomized Trial.
   Huaman JW, Mego M, Bendezú A, Monrroy H, et al · · 2020 · cited 10× · PMID 31811952 · DOI 10.1016/j.cgh.2019.11.048