Acute DiarrheaPhase 2NCT01269892
Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
A Phase 2 study testing lactose-free milk and conventional milk in people with Acute Diarrhea, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes. Read more about this study
- Who is it for?
- Ages 3 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Diarrhea
- What is being tested?
- lactose-free milk and conventional milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIran
- Study dates
- Jan 2009to Aug 2009
- Phase
- Phase 2
- 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 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with acute non-bloody diarrhea (≤ 2 weeks)
- mild to moderate dehydration
Who cannot join
- mucous bloody stools
- major systemic illness
- severe malnutrition (Weight for age <60% and Weight for height <70 %)
- history of antibiotics receiving
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Nutritional Regime for Acute Diarrhea
The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.
Read the detailed description
Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.
- Conditions
- Acute Diarrhea
- Being tested
- lactose-free milk, conventional milk
- Keywords
- diarrhea, lactose, milk, weight, acute.
- Medical subject headings
- Diarrhea, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactose-free milkDietary supplement
Also called nothing
a milk without lactose
conventional milkDietary supplement
Also called nothing
a milk with lactose
| Study group | Role | What they receive |
|---|---|---|
| lactose-free milk | Other | it is kind of nutritional regime Receives: Dietary Supplement: lactose-free milk |
| conventional milk | Other | it is kind of nutritional regime Receives: Dietary Supplement: conventional milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of diarrhea
Duration of diarrhea corresponded to the time from enrollment to the cessation of diarrhea, which was defined as the passage of the last watery or loose stool before passage of two consecutive formed stools or no stool in a 24-hour period.
Measured: at seven days after admission
Secondary outcomes (1)
changes in weight gaining
nude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission
Measured: at seven days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ali Gholamrezaei, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269892
- Sponsor's protocol ID
- ASD-1213-9
- Status last verified
- Jan 2009
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nutritional Regime for Acute Diarrhea
- ClinicalTrials.gov ID
- NCT01269892
- Acronym / sponsor ID
- ASD-1213-9
- Conditions
- Acute Diarrhea
- Keywords
- diarrhea, lactose, milk, weight, acute.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Jan 2011 (estimated)
- 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.
The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.
Detailed description
Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lactose-free milk | Other | Dietary Supplement: lactose-free milkit is kind of nutritional regime |
| conventional milk | Other | Dietary Supplement: conventional milkit is kind of nutritional regime |
Who may qualify
- Ages
- 3 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with acute non-bloody diarrhea (≤ 2 weeks)
- mild to moderate dehydration
Key exclusion criteria (4 listed)
- mucous bloody stools
- major systemic illness
- severe malnutrition (Weight for age <60% and Weight for height <70 %)
- history of antibiotics receiving
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 |
|---|---|---|
| lactose-free milkAlso: nothinga milk without lactose | Dietary supplement | lactose-free milk |
| conventional milkAlso: nothinga milk with lactose | Dietary supplement | conventional milk |
Primary outcome
duration of diarrhea
Time frame: at seven days after admission
Duration of diarrhea corresponded to the time from enrollment to the cessation of diarrhea, which was defined as the passage of the last watery or loose stool before passage of two consecutive formed stools or no stool in a 24-hour period.
1 secondary outcome
changes in weight gaining
Time frame: at seven days after admission
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 4 Jan 2011.
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Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
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Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3
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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.
Ali Gholamrezaei, MD study chair
MD,research comittee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lactose-free milk and conventional milk in people with Acute Diarrhea, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 2 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 4 Jan 2011. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
duration of diarrhea (time frame: at seven days after admission). 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 4 Jan 2011.