NCT02956187

Treatment of Constipation in Functional Dyspepsia

Effect of Treatment of Constipation on Dyspeptic Symptoms in Patients With Constipation and Functional Dyspepsia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Dyspepsia
• Constipation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-06-12
• Primary completion: 2017-12-10
• Completion: 2018-01-08
• First posted: 2016-11-07
• Last updated: 2018-01-19

Locations

1 site across 1 country: Spain