Treatment of Constipation in Functional Dyspepsia
Primary Purpose
Dyspepsia, Constipation
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Biofeedback
Fiber supplement
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia
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.
Sites / Locations
- Fernando Azpiroz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biofeedback for constipation
Fiber supplementation
Arm Description
Constipation will be treated by correcting functional outlet obstruction.
Constipation will be treated by a fiber supplement
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02956187
First Posted
August 4, 2016
Last Updated
January 18, 2018
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02956187
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 12, 2016 (undefined)
Primary Completion Date
December 10, 2017 (Actual)
Study Completion Date
January 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback for constipation
Arm Type
Experimental
Arm Description
Constipation will be treated by correcting functional outlet obstruction.
Arm Title
Fiber supplementation
Arm Type
Active Comparator
Arm Description
Constipation will be treated by a fiber supplement
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
Functional outlet obstruction will be treated by biofeedback: sessions of biofeedback guided by anorectal manometry combined with instructions for daily exercizing for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fiber supplement
Intervention Description
3.5 g plantago ovata per day will be administered for 4 weeks.
Primary Outcome Measure Information:
Title
Change in clinical symptoms of functional dyspepsia during treatment versus before.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in postprandial abdominal fullness measured after a test meal by the end of treatment versus before
Description
Change in average postprandial abdominal fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Azpiroz, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fernando Azpiroz
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31811952
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.
Results Reference
derived
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Treatment of Constipation in Functional Dyspepsia
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