Acute Watery DiarrheaPhase 1NCT05216822
Anti-Secretory Drug in Treatment of Acute Watery Diarrhea
A Phase 1 study testing Racecadotril in people with Acute Watery Diarrhea, run by Assiut University at 1 site in Egypt.
Trial summary
In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Watery Diarrhea
- What is being tested?
- Racecadotril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 31 Aug 2018
- Phase
- Phase 1
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group for six months - 5 years.
- No or mild to moderate dehydration.
- Alert patient (to tolerate oral intake since the drug is only available in oral form).
Who cannot join
- Patients with severe dehydration (inability to drink because of drowsiness).
- Patients with any serious concomitant illness that needs antibiotic treatment.
- If severe adverse events occur at any time.
- Chronic diarrhea.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Anti-Secretory Drug in Treatment of Children With Acute Watery Diarrhea
In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.
Read the detailed description
Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.
- Conditions
- Acute Watery Diarrhea
- Being tested
- Racecadotril
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacecadotrilDrug
Also called Acetorphan
racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days
| Study group | Role | What they receive |
|---|---|---|
| children received ORS and racecadotril as treatment | Experimental | 25 children received ORS and racecadotril as treatment (at a dose of 1.5 mg/kg/day, an oral single daily dose for three days) Receives: Drug: Racecadotril |
| children received ORS alone as treatment | Active comparator | 25 children received ORS alone for treatment as a control group Receives: Drug: Racecadotril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrheal episode
number
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jun 2018
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Watery DiarrheaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Roshdy Elkhayat, Assiut University
- Investigators
- Hamada M Kamel, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216822
- Sponsor's protocol ID
- IRB-2/2019AZA
- Status last verified
- Jan 2022
- First submitted
- 6 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anti-Secretory Drug in Treatment of Children With Acute Watery Diarrhea
- ClinicalTrials.gov ID
- NCT05216822
- Acronym / sponsor ID
- IRB-2/2019AZA
- Conditions
- Acute Watery Diarrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 1 Feb 2022 (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.
In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.
Detailed description
Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children received ORS and racecadotril as treatment | Experimental | Drug: Racecadotril25 children received ORS and racecadotril as treatment (at a dose of 1.5 mg/kg/day, an oral single daily dose for three days) |
| children received ORS alone as treatment | Active comparator | Drug: Racecadotril25 children received ORS alone for treatment as a control group |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age group for six months - 5 years.
- No or mild to moderate dehydration.
- Alert patient (to tolerate oral intake since the drug is only available in oral form).
Key exclusion criteria (4 listed)
- Patients with severe dehydration (inability to drink because of drowsiness).
- Patients with any serious concomitant illness that needs antibiotic treatment.
- If severe adverse events occur at any time.
- Chronic diarrhea.
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 |
|---|---|---|
| RacecadotrilAlso: Acetorphanracecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days | Drug | children received ORS alone as treatment, children received ORS and racecadotril as treatment |
Primary outcome
Diarrheal episode
Time frame: 1-3 months
number
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Watery Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Recruiting
Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
Acute Watery Diarrhea
Active, not recruiting
Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3
Acute Watery Diarrhea
Active, not recruiting
Comparison of Low Osmolar ORS and ReSoMal for Treating Acute Watery Diarrhea in Severely Malnourished Children Aged 6 Months to 5 Years
Acute Watery Diarrhea, Severe Acute Malnutrition in Childhood
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.
Hamada M Kamel, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Racecadotril in people with Acute Watery Diarrhea, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrheal episode (time frame: 1-3 months). 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 1 Feb 2022.