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Treatment of Constipation in Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT02956187
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Dyspepsia Constipation Behavioral: Biofeedback Dietary Supplement: Fiber supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Spain
Fernando Azpiroz
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Fernando Azpiroz, MD Principal Investigator

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02956187     History of Changes
Other Study ID Numbers: PR(AG)181/2016
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Constipation
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms