Clinical trial NCT02956187: Treatment of Constipation in Functional Dyspepsia
Official title: Effect of Treatment of Constipation on Dyspeptic Symptoms in Patients With Constipation and Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Constipation
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Patients with functional dyspepsia and functional constipation.

Inclusion Criteria

* Rome IV criteria for functional dyspepsia type of postprandial distress syndrome.
* Rome IV criteria of functional constipation
* Anorectal manometry showing defective sphincter relaxation during the defecatory manoeuver.

Exclusion Criteria:

* History of organic gastrointestinal disorders
* Cognitive impairment.

Primary outcomes:
measure: Change in clinical symptoms of functional dyspepsia during treatment versus before.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in postprandial abdominal fullness measured after a test meal by the end of treatment versus before
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fernando Azpiroz
Study officials:
affiliation: Principal Investigator
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huaman JW, Mego M, Bendezu A, Monrroy H, Samino S, Accarino A, Saperas E, Azpiroz F. Correction of Dyssynergic Defecation, but Not Fiber Supplementation, Reduces Symptoms of Functional Dyspepsia in Patients With Constipation in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2463-2470.e1. doi: 10.1016/j.cgh.2019.11.048. Epub 2019 Dec 4.