Treatment of Constipation in Functional Dyspepsia

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956187
• Other study ID #: PR(AG)181/2016
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: January 18, 2018
• Start date: June 12, 2016
• Est. completion date: January 8, 2018

Study information

• Verified date: September 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 8, 2018
• Est. primary completion date: December 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Dyspepsia

Intervention

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.

Locations

Country	Name	City	State
Spain	Fernando Azpiroz	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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