| CTRI Number |
CTRI/2024/04/066510 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Other |
|
Public Title of Study
|
The efficacy and safety of probiotics in treating children with chronic abdominal pain |
|
Scientific Title of Study
|
Efficacy and Safety of Polystrain Probiotics for Chronic Abdominal Pain in children aged 7-14 years: A Prospective, Open-labelled, Randomised, Parallel Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savita Verma |
| Designation |
Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak |
| Address |
3rd floor, Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9812283746 |
| Fax |
|
| Email |
verma.savi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Vashisth |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak |
| Address |
3rd floor, Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9817376219 |
| Fax |
|
| Email |
sapnavashisth.4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna Vashisth |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak |
| Address |
3rd floor, Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9817376219 |
| Fax |
|
| Email |
sapnavashisth.4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana - 124001 |
|
|
Primary Sponsor
|
| Name |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana - 124001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sapna Vashisth |
Department of Pediatrics |
Paediatric department, Room no.221,1st Floor, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak Haryana 124001
Rohtak
HARYANA |
9817376219
sapnavashisth.4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Polystrain Probiotics, BIFILAC HP |
Twice a Day as an add on to Standard of care for 2 weeks |
| Comparator Agent |
Standard of care |
For 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Abdominal Pain diagnosed according to ROME 4 Criteria.
Legally Authorized Representative/Participants willing to give
assent/consent for the study. |
|
| ExclusionCriteria |
| Details |
Organic pain warning signs (includes
age under 5, right upper and right
lower abdominal pain, failure to
thrive).
Having organic disease (urinary tract
infection, celiac disease, parasites,
etc.) and other chronic diseases.
Patient on Antibiotics, Prokinetics.
Acute Infection.
Undergone abdominal surgery within
1 month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in pain in study population
ï‚Ÿ Severity/Intensity
ï‚Ÿ Frequency
ï‚Ÿ Duration
2. Change in Quality of Life (QoL) in study population |
2nd week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of patients requiring escape treatment
2. Adherence to treatment |
2nd week |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/05/2024 |
| Date of Study Completion (India) |
12/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic abdominal pain is a common disorder affecting school- going children and often results in significantly low attendance rates and high school absenteeism. Since the pathophysiology of CAP is poorly understood and there is limited data regarding the efficacy and safety of the few therapeutic options available, management of CAP in children can be challenging. Probiotics have shown potential as microbiota modulators in various Gastro Intestinal Disorders. However, there is limited research available evaluating the efficacy and safety of probiotics in managing CAP in children. Therefore, this study is undertaken to investigate the effect of polystrain probiotics in children suffering from chronic abdominal pain. The eligible patients will be randomly allocated to 2 treatment groups: Group A and Group B (n=66 in each group) • Group A will be given Polystrain Probiotics twice a day as an add-on to standard of care for 2 weeks. • Group B will be given standard of care for 2 weeks. |