Treatment of Constipation in Functional Dyspepsia

Not Applicable

Completed

• Conditions: Dyspepsia; Constipation
• Interventions: Behavioral: Biofeedback; Dietary Supplement: Fiber supplement

• Registration Number: NCT02956187
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-12
• Study First Submitted: 2016-08-04
• Status Verified: 2016-09
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-06
• Primary Completion: 2017-12-10
• Study Completion: 2018-01-08
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• History of organic gastrointestinal disorders
• Cognitive impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback for constipation	Biofeedback	Constipation will be treated by correcting functional outlet obstruction.
Fiber supplementation	Fiber supplement	Constipation will be treated by a fiber supplement

Primary Outcome Measures

Name	Time	Method
Change in clinical symptoms of functional dyspepsia during treatment versus before.	4 weeks	Change in average postprandial abdominal fullness measured daily by 0-10 score scales for 7 consecutive days before and during the last week of intervention.

Secondary Outcome Measures

Name	Time	Method
Change in postprandial abdominal fullness measured after a test meal by the end of treatment versus before	4 weeks	Change in average postprandial abdominal fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.

Trial Locations

Locations (1)

Fernando Azpiroz; 🇪🇸 Barcelona, Spain