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CTRI Number  CTRI/2025/01/079507 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [BIOFEEDBACK THERAPY]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Biofeedback therapy in a subgroup of functional constipation children with Dyssynergic defecation between 5-12 years - A randomised control trial 
Scientific Title of Study   Prevalence of Dyssynergic Defecation among children aged 5 to 12 years with Functional constipation and the role of biofeedback therapy among children with Dyssynergic Defecation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepa J 
Designation  Senior Resident 
Affiliation  Institute of child health and hospital for children,  
Address  Department of Pediatric Gastroenterology, Institute of child health and hospital for children, Halls road, egmore 600008

Chennai
TAMIL NADU
600008
India 
Phone  9445383688  
Fax    
Email  rdherdhe9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepa J 
Designation  Senior Resident 
Affiliation  Institute of child health and hospital for children 
Address  Department of Pediatric Gastroenterology, Institute of child health and hospital for children, Halls road, Egmore 600008

Chennai
TAMIL NADU
600008
India 
Phone  9445383688  
Fax    
Email  rdherdhe9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepa J 
Designation  Senior Resident 
Affiliation  Institute of child health and hospital for children 
Address  Department of Pediatric Gastroenterology, Institute of child health and hospital for children, Halls road, Egmore 600008

Chennai
TAMIL NADU
600008
India 
Phone  9445383688  
Fax    
Email  rdherdhe9@gmail.com  
 
Source of Monetary or Material Support  
Department of pediatric gastroenterology, Institute of child health and hospital for children, Madras Medical College 
 
Primary Sponsor  
Name  Department of Paediatric Gastroenterology 
Address  Institute of child health and Hospital for children, Halls road, Egmore 600008  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepa J  INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN  DEPARTMENT OF PEDIATRIC GASTROENTEROLOGY, C BLOCK 5th Floor, INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN, HALLS ROAD, EGMORE 600008
Chennai
TAMIL NADU 		 09445383688

rdherdhe9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE MADRAS MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BIOFEEDBACK THERAPY WITH LAXATIVES   Biofeedback therapy using Anorectal manometry to enable them to visualize and reinforce on the technique of anal sphincter relaxation targeting on the appropriate pressures in anal canal and rectum based on the baseline manometry. Biofeedback therapy will be done for six sessions, one session a week, each session lasting for 40-45 minutes. Biofeedback therapy with laxatives will be compared to laxatives alone for the control of symptoms every week in the first month and monthly thereafter till 3 months. The changes in Anorectal manometry will be noted at the recruitment and at 3 months.  
Comparator Agent  LAXATIVES  Laxatives will be given at the standard dose for maintenance treatment in constipation i.e. 0.5-1.0mg/kg/day daily. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between 5year to 12 years of age diagnosed with functional constipation fulfilling ROME IV criteria and diagnosed with Dyssynergic defecation by anorectal manometry in Institute of Child health and Hospital for Children 
 
ExclusionCriteria 
Details  1. Non Retentive Encopresis
2. Organic Cause of constipation
3. Developmental delay, Cognitive disabilities 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine whether biofeedback therapy in addition to standard laxative treatment is superior for treatment of Dyssynergic Defecation among children aged 5 to 12 years.  Symptom improvement monitoring at 1 week, 2 week, 1 month, 2 months and 3 months and Anorectal manometry at the time of recruitment and at the end of 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the response and the changes in anorectal manometry after standard laxative treatment and biofeedback plus laxative  AT the end of 3 months after starting treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  In the institute along with the researcher

  6. For how long will this data be available start date provided 15-09-2025 and end date provided 01-12-2035?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Functional constipation is a leading cause of pediatric gastroenterologist consultations, comprising approximately 25% of cases, with a prevalence rate of up to 32.2%. As of now, there is no consensus as to how long to continue treatment for functional constipation in children and there is paucity of data on High resolution anorectal manometry findings in children with functional constipation. Studies have reported the prevalence of Dyssynergic defecation in children till 80%. Dyssynergic defecation (DD) is one of the cause of failure of standard treatment and longer treatment. Biofeedback id the mainstay of treatment for adults with Dyssynergic defecation At present, due to under recognition and underreporting of this entity, diagnostic criteria for DD are based on studies in adults and the utility of biofeedback is hardly studied in children. Hence this study is aimed at determining the role of biofeedback with laxatives compared to laxatives.

 

Hypothesis: As Dyssynergic Defecation is increasingly prevalent in the children with constipation between 5-12 years, and high rate of incomplete cure and relapse is identified, it is hypothesized that treatment with biofeedback therapy  in addition to laxatives will achieve a higher rate of response compared to the group of laxatives alone.

 
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