Treatment of Constipation in Functional Dyspepsia
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|ClinicalTrials.gov Identifier: NCT02956187|
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : January 19, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia Constipation||Behavioral: Biofeedback Dietary Supplement: Fiber supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Treatment of Constipation on Dyspeptic Symptoms in Patients With Constipation and Functional Dyspepsia|
|Study Start Date :||June 12, 2016|
|Actual Primary Completion Date :||December 10, 2017|
|Actual Study Completion Date :||January 8, 2018|
Experimental: Biofeedback for constipation
Constipation will be treated by correcting functional outlet obstruction.
Functional outlet obstruction will be treated by biofeedback: sessions of biofeedback guided by anorectal manometry combined with instructions for daily exercizing for 4 weeks.
Active Comparator: Fiber supplementation
Constipation will be treated by a fiber supplement
Dietary Supplement: Fiber supplement
3.5 g plantago ovata per day will be administered for 4 weeks.
- Change in clinical symptoms of functional dyspepsia during treatment versus before. [ Time Frame: 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.
- Change in postprandial abdominal fullness measured after a test meal by the end of treatment versus before [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956187
|Barcelona, Spain, 08035|
|Principal Investigator:||Fernando Azpiroz, MD||Principal Investigator|