Acute Watery DiarrheaNCT07392931
Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea
A study testing Racecadotril in people with Acute Watery Diarrhea, run by Punjab Rangers Teaching Hospital Lahore at 1 site in Pakistan.
Trial summary
Acute watery diarrhea is a common cause of illness and hospitalization in children under five years of age, particularly in developing countries. The mainstay of treatment is oral rehydration therapy, which prevents dehydration but does not reduce stool frequency or duration of diarrhea. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Acute Watery Diarrhea
- What is being tested?
- Racecadotril
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 30 Nov 2025
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:Children aged 3 months to 5 years Diagnosis of acute watery diarrhea Duration of illness ≤ 72 hours Written informed consent obtained from parents or legal guardians
Exclusion Criteria:Chronic diarrhea Severe malnutrition Severe dehydration requiring intensive care Known hypersensitivity to racecadotril Presence of serious underlying systemic illness Patient with bloody mucus containing diarrhea
-
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Punjab Rangers Teaching Hospital Lahore
Lahore, Punjab Province, 53720
About this study
Official title: Safety and Efficacy of Racecadotril in the Treatment of Acute Watery Diarrhea in Children: A Randomized Controlled Trial
Acute watery diarrhea is a common cause of illness and hospitalization in children under five years of age, particularly in developing countries. The mainstay of treatment is oral rehydration therapy, which prevents dehydration but does not reduce stool frequency or duration of diarrhea. Persistent diarrhea often leads to repeated hospital visits and increased healthcare burden.
This randomized controlled trial was conducted to evaluate the safety and efficacy of racecadotril as an adjunct to standard oral rehydration therapy in children aged 3 months to 5 years hospitalized with acute watery diarrhea. Participants were randomly assigned to receive either racecadotril in addition to standard therapy or placebo with standard therapy.
The primary outcomes assessed were reduction in stool frequency and improvement in stool consistency, along with duration of hospital stay. The study aimed to determine whether racecadotril provides additional clinical benefit when used alongside standard treatment in pediatric acute watery diarrhe
Read the detailed description
Acute watery diarrhea is a leading cause of morbidity and hospitalization among children under five years of age. Although oral rehydration therapy (ORT) remains the cornerstone of management, it does not reduce stool output, frequency, or duration of diarrhea. Racecadotril is an antisecretory agent that reduces intestinal fluid secretion without affecting gastrointestinal motility and has been shown to be safe in pediatric populations.
This study was a single-center, randomized, placebo-controlled clinical trial conducted in the Pediatric Department of Punjab Rangers Teaching Hospital, Lahore. Children aged 3 months to 5 years of either gender presenting with acute watery diarrhea were enrolled after obtaining informed consent from parents or guardians. Acute diarrhea was defined as the passage of three or more watery stools within 24 hours with a duration of less than 72 hours.
Participants were randomized using a lottery method into two groups. The intervention group received racecadotril at a dose of 1.5 mg/kg three times daily as an adjunct to standard oral rehydration therapy and intravenous fluids when indicated. The control group received placebo along with the same standard therapy. The study was conducted under single-blind conditions.
Children with severe dehydration, chronic diarrhea, blood or mucus in stools, age below 3 months, or significant comorbidities were excluded. Clinical outcomes were assessed by monitoring stool frequency, stool consistency, and duration of hospital stay.
The study was conducted over a six-month period from June 2025 to November 2025. Ethical approval was obtained from the Ethical Committee of Punjab Rangers Teaching Hospital, Lahore. Data were analyzed using SPSS software, with results expressed as means, standard deviations, frequencies, and percentages.
- Conditions
- Acute Watery Diarrhea
- Being tested
- Racecadotril, Placebo
- Keywords
- Racecadotril, Pediatric Diarrhea, Acute Gastroenteritis, Oral Rehydration Therapy, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacecadotrilDrug
Racecadotril was administered orally at a dose of 1.5 mg/kg three times daily as an adjunct to standard therapy for acute watery diarrhea.
PlaceboOther
Placebo was administered orally along with standard therapy for acute watery diarrhea.
| Study group | Role | What they receive |
|---|---|---|
| Racecadotril plus Standard Therapy | Experimental | Participants received racecadotril in addition to standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated. Receives: Drug: Racecadotril |
| Placebo plus Standard Therapy | Placebo comparator | Participants received placebo along with standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
Time from initiation of treatment until passage of the last unformed stool.
Measured: Up to 72 hours after initiation of treatment
Reduction in stool frequency
Change in the number of watery stools per day after initiation of treatment.
Measured: Within 12 hours of treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
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.
- 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
- Model description
- A randomized, parallel-group, placebo-controlled clinical trial comparing racecadotril plus standard therapy with placebo plus standard therapy in children with acute watery diarrhea
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Punjab Rangers Teaching Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Own Abbas, Punjab Rangers Teaching Hospital Lahore
- Investigators
- Own Abbas, Principal investigator, Punjab Rangers Teaching Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392931
- Sponsor's protocol ID
- RCT-2026-01
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Racecadotril in the Treatment of Acute Watery Diarrhea in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07392931
- Acronym / sponsor ID
- RCT-2026-01
- Conditions
- Acute Watery Diarrhea
- Keywords
- Racecadotril, Pediatric Diarrhea, Acute Gastroenteritis, Oral Rehydration Therapy, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Punjab Rangers Teaching Hospital LahoreUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 6 Feb 2026 (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.
Acute watery diarrhea is a common cause of illness and hospitalization in children under five years of age, particularly in developing countries. The mainstay of treatment is oral rehydration therapy, which prevents dehydration but does not reduce stool frequency or duration of diarrhea. Persistent diarrhea often leads to repeated hospital visits and increased healthcare burden.
This randomized controlled trial was conducted to evaluate the safety and efficacy of racecadotril as an adjunct to standard oral rehydration therapy in children aged 3 months to 5 years hospitalized with acute watery diarrhea. Participants were randomly assigned to receive either racecadotril in addition to standard therapy or placebo with standard therapy.
The primary outcomes assessed were reduction in stool frequency and improvement in stool consistency, along with duration of hospital stay. The study aimed to determine whether racecadotril provides additional clinical benefit when used alongside standard treatment in pediatric acute watery diarrhe
Detailed description
Acute watery diarrhea is a leading cause of morbidity and hospitalization among children under five years of age. Although oral rehydration therapy (ORT) remains the cornerstone of management, it does not reduce stool output, frequency, or duration of diarrhea. Racecadotril is an antisecretory agent that reduces intestinal fluid secretion without affecting gastrointestinal motility and has been shown to be safe in pediatric populations.
This study was a single-center, randomized, placebo-controlled clinical trial conducted in the Pediatric Department of Punjab Rangers Teaching Hospital, Lahore. Children aged 3 months to 5 years of either gender presenting with acute watery diarrhea were enrolled after obtaining informed consent from parents or guardians. Acute diarrhea was defined as the passage of three or more watery stools within 24 hours with a duration of less than 72 hours.
Participants were randomized using a lottery method into two groups. The intervention group received racecadotril at a dose of 1.5 mg/kg three times daily as an adjunct to standard oral rehydration therapy and intravenous fluids when indicated. The control group received placebo along with the same standard therapy. The study was conducted under single-blind conditions.
Children with severe dehydration, chronic diarrhea, blood or mucus in stools, age below 3 months, or significant comorbidities were excluded. Clinical outcomes were assessed by monitoring stool frequency, stool consistency, and duration of hospital stay.
The study was conducted over a six-month period from June 2025 to November 2025. Ethical approval was obtained from the Ethical Committee of Punjab Rangers Teaching Hospital, Lahore. Data were analyzed using SPSS software, with results expressed as means, standard deviations, frequencies, and percentages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, parallel-group, placebo-controlled clinical trial comparing racecadotril plus standard therapy with placebo plus standard therapy in children with acute watery diarrhea
| Arm | Type | Receives |
|---|---|---|
| Racecadotril plus Standard Therapy | Experimental | Drug: RacecadotrilParticipants received racecadotril in addition to standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated. |
| Placebo plus Standard Therapy | Placebo comparator | Other: PlaceboParticipants received placebo along with standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| RacecadotrilRacecadotril was administered orally at a dose of 1.5 mg/kg three times daily as an adjunct to standard therapy for acute watery diarrhea. | Drug | Racecadotril plus Standard Therapy |
| PlaceboPlacebo was administered orally along with standard therapy for acute watery diarrhea. | Other | Placebo plus Standard Therapy |
Primary outcome
Duration of diarrhea
Time frame: Up to 72 hours after initiation of treatment
Time from initiation of treatment until passage of the last unformed stool.
Reduction in stool frequency
Time frame: Within 12 hours of treatment initiation
Change in the number of watery stools per day after initiation of treatment.
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 6 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations.
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.
Own Abbas principal investigator
Punjab Rangers Teaching Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Racecadotril in people with Acute Watery Diarrhea, run by Punjab Rangers Teaching Hospital Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Feb 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
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?
Duration of diarrhea (time frame: Up to 72 hours after initiation of treatment). The study lists 2 primary outcomes in all. 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 6 Feb 2026.