DiarrheaNCT04885049
Comparing the Efficacy of Anti-secretory Versus Oral Immunoglobulins for Reducing the Episodes of Diarrhea in Children
A study testing Racecadotril and DiaResQ Children's Powder for Suspension in people with Diarrhea, run by Shaheed Zulfiqar Ali Bhutto Medical University.
Trial summary
Children 1-12 years presenting/admitted with acute diarrhea will be enrolled in the study after taking informed consent from the parents. Patients will be randomly allocated to two equal groups. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Racecadotril and DiaResQ Children's Powder for Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 1-12 years both male and female visiting/admitted in Children Hospital PIMS with acute diarrhea of less than 15 days duration
Who cannot join
- Children requiring emergency resuscitation.
- Children having diarrhea of more than 15 days duration..
- Children with other comorbid conditions like heart, kidney and liver failure.
- Children with fructose intolerance, glucose malabsorption syndrome and saccharase isomaltase deficiency.
- Children allergic to egg or any of the contents.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial Comparing the Efficacy of Anti Secretory and Oral Immunoglobulins Reducing the Episodes of Diarrhea in Children
Children 1-12 years presenting/admitted with acute diarrhea will be enrolled in the study after taking informed consent from the parents. Patients will be randomly allocated to two equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose, three doses in 24 hours along with oral rehydration, while Group B (GB) will receive a single dose of bovine immunoglobulins. Response to treatment will be assessed by recording the frequency of loose stools after 72 hrs. Data will be collected through a structured proforma.
Read the detailed description
It is a randomized clinical trial that will be conducted at Children Hospital PIMS, Islamabad over the period of 6 months. Sample size is calculated using World Health Organization (WHO) calculator, keeping confidence level 95%, level of significance 5%, power of the test 80%,anticipated population proportion 1: 84%, anticipated population proportion 2: 93%, which turn out to be 30.Consecutive non probability sampling technique will be used. Children 1-12 years both male and female visiting/admitted in Children Hospital PIMS with acute diarrhea of less than 15 days duration will be enrolled in the study after taking informed consent from the parents. Children requiring emergency resuscitation, having chronic diarrhea i-e more than 15 days duration, having other comorbid conditions like heart, kidney and liver failure, having metabolic disorder and who are allergic to egg or any of the contents will be excluded from the study.
Child's name, age, sex will be recorded by the on duty doctor. Patients will be randomly allocated to two equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose three doses per oral in 24 hours along with oral rehydration, while Group B (GB) will receive a single dose of bovine colostrum and egg solids as 7 g of dry powder reconstituted in 30 mL of water and taken orally once daily for 3 days along with oral rehydration. Response to treatment will be assessed by recording the reduction in frequency of diarrheal episodes after administration of drug and duration in which the diarrheal episodes were reduced. Data will be collected through a structured proforma.
All data will be analyzed using latest SPSS version. Quantitative variables such as age, time will be presented as means and standard deviations. Qualitative variables such as age groups, sex, recurrence of seizures and efficacy will be measured as frequency and percentages. Effect modifiers like age, gender will be controlled by stratification. Post stratification chi-square test will be applied keeping p value ≤0.05 as significant.
- Conditions
- Diarrhea
- Being tested
- Racecadotril, DiaResQ Children's Powder for Suspension
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacecadotrilDrug
Anti secretary
DiaResQ Children's Powder for SuspensionDrug
oral immunoglobulins
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A (GA) will receive anti secretory 1.5mg/kg/dose three doses per oral in 24 hours for 3 days along with oral rehydration Receives: Drug: Racecadotril |
| Group B | Experimental | Group B (GB) will receive a single dose of bovine colostrum and egg solids as 7 g of dry powder reconstituted in 30 mL of water and taken orally once daily for 3 days along with oral rehydration Receives: Drug: DiaResQ Children's Powder for Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of diarrheal episodes
reduction in frequency of diarrheal episodes after administration of drug
Measured: 24 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nighat Haider, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Nighat Haider, FCPS, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885049
- Sponsor's protocol ID
- No.F.1-1/2015/ERB/SZABMU/556
- Status last verified
- Aug 2021
- First submitted
- 9 May 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If somebody wants the IPD they can email the principal investigator and it will be provided after the publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy of Anti Secretory and Oral Immunoglobulins Reducing the Episodes of Diarrhea in Children
- ClinicalTrials.gov ID
- NCT04885049
- Acronym / sponsor ID
- No.F.1-1/2015/ERB/SZABMU/556
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children 1-12 years presenting/admitted with acute diarrhea will be enrolled in the study after taking informed consent from the parents. Patients will be randomly allocated to two equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose, three doses in 24 hours along with oral rehydration, while Group B (GB) will receive a single dose of bovine immunoglobulins. Response to treatment will be assessed by recording the frequency of loose stools after 72 hrs. Data will be collected through a structured proforma.
Detailed description
It is a randomized clinical trial that will be conducted at Children Hospital PIMS, Islamabad over the period of 6 months. Sample size is calculated using World Health Organization (WHO) calculator, keeping confidence level 95%, level of significance 5%, power of the test 80%,anticipated population proportion 1: 84%, anticipated population proportion 2: 93%, which turn out to be 30.Consecutive non probability sampling technique will be used. Children 1-12 years both male and female visiting/admitted in Children Hospital PIMS with acute diarrhea of less than 15 days duration will be enrolled in the study after taking informed consent from the parents. Children requiring emergency resuscitation, having chronic diarrhea i-e more than 15 days duration, having other comorbid conditions like heart, kidney and liver failure, having metabolic disorder and who are allergic to egg or any of the contents will be excluded from the study.
Child's name, age, sex will be recorded by the on duty doctor. Patients will be randomly allocated to two equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose three doses per oral in 24 hours along with oral rehydration, while Group B (GB) will receive a single dose of bovine colostrum and egg solids as 7 g of dry powder reconstituted in 30 mL of water and taken orally once daily for 3 days along with oral rehydration. Response to treatment will be assessed by recording the reduction in frequency of diarrheal episodes after administration of drug and duration in which the diarrheal episodes were reduced. Data will be collected through a structured proforma.
All data will be analyzed using latest SPSS version. Quantitative variables such as age, time will be presented as means and standard deviations. Qualitative variables such as age groups, sex, recurrence of seizures and efficacy will be measured as frequency and percentages. Effect modifiers like age, gender will be controlled by stratification. Post stratification chi-square test will be applied keeping p value ≤0.05 as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: RacecadotrilGroup A (GA) will receive anti secretory 1.5mg/kg/dose three doses per oral in 24 hours for 3 days along with oral rehydration |
| Group B | Experimental | Drug: DiaResQ Children's Powder for SuspensionGroup B (GB) will receive a single dose of bovine colostrum and egg solids as 7 g of dry powder reconstituted in 30 mL of water and taken orally once daily for 3 days along with oral rehydration |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 1-12 years both male and female visiting/admitted in Children Hospital PIMS with acute diarrhea of less than 15 days duration
Key exclusion criteria (5 listed)
- Children requiring emergency resuscitation.
- Children having diarrhea of more than 15 days duration..
- Children with other comorbid conditions like heart, kidney and liver failure.
- Children with fructose intolerance, glucose malabsorption syndrome and saccharase isomaltase deficiency.
- Children allergic to egg or any of the contents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RacecadotrilAnti secretary | Drug | Group A |
| DiaResQ Children's Powder for Suspensionoral immunoglobulins | Drug | Group B |
Primary outcome
frequency of diarrheal episodes
Time frame: 24 to 72 hours
reduction in frequency of diarrheal episodes after administration of drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: Yes. If somebody wants the IPD they can email the principal investigator and it will be provided after the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nighat Haider, FCPS principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Racecadotril and DiaResQ Children's Powder for Suspension in people with Diarrhea, run by Shaheed Zulfiqar Ali Bhutto Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nighat Haider, FCPS (+92519107695, nighathaider@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of diarrheal episodes (time frame: 24 to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.