Treatment of Constipation in Functional Dyspepsia

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

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).

Study Overview

• Status: Completed
• Conditions: Dyspepsia; Constipation
• Intervention / Treatment: Behavioral: Biofeedback; Dietary supplement: Fiber supplement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Fernando Azpiroz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Biofeedback for constipation; Constipation will be treated by correcting functional outlet obstruction.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical symptoms of functional dyspepsia during treatment versus before.	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.	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Fernando Azpiroz, MD, Principal Investigator

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 12, 2016
• Primary Completion (ACTUAL): December 10, 2017
• Study Completion (ACTUAL): January 8, 2018

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (ESTIMATE): November 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Constipation
• Other Study ID Numbers: PR(AG)181/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO