Acute GastroenteritisNCT02246010
Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
A study testing Lactose- free milk in people with Acute Gastroenteritis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea. Read more about this study
- Who is it for?
- Ages 2 to 18 months
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Lactose- free milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2015to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants on artificial milk formula
- Presenting to the ED or pediatric clinics of the American University of Beirut Medical Center
- Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24 hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or without fever, vomiting, mucus or blood per stools).
Who cannot join
- Exclusively or partially breast-fed infants
- Severe dehydration requiring hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.
Read the detailed description
Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15 % of all childhood death worldwide, and is a major public health burden, especially in developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials reported a modest reduction in the duration of diarrhea in children younger than 5 years who were on reduced or lactose-free diet. Those trials however were conducted on inpatients in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. This study aims at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants from a developing country, who present with acute gastroenteritis to the Emergency Department (ED) or pediatric clinics. The findings from this study will help provide evidence-based dietary recommendations for infants with acute diarrhea in developing countries who are treated in the ambulatory setting.
- Conditions
- Acute Gastroenteritis
- Being tested
- Lactose- free milk
- Keywords
- diarrhea, developing world, lactose-free diet, Clinical trial
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose- free milkDietary supplement
Lactose- free milk
| Study group | Role | What they receive |
|---|---|---|
| Lactose-free milk | Experimental | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Receives: Dietary Supplement: Lactose- free milk |
| Regular infant milk | No intervention | Regular infant milk formula and anti-diarrheic diet for 7 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea Duration
number of days with 3 or more loose or watery stools
Measured: From onset of illness till the day of last diarrheic stool passed.
Secondary outcomes (4)
Weight Loss
Percent weight loss from baseline
Measured: 7 days
Illness Visits
Number of participants with illness visits
Measured: 7 days
Hospitalization Rate
Rate of hospitalization
Measured: 7 days
Parental Satisfaction
Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study start1 Jul 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Why it stopped: Very slow recruitment rate. Only 6 infants were recruited over 2 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies 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
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Nabulsi, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246010
- Sponsor's protocol ID
- PED.MN.09
- Status last verified
- Jan 2019
- First submitted
- 18 Sep 2014
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nabulsi M, Yazbeck N, Charafeddine F. Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:46. doi: 10.1186/s13063-015-0565-9.
PubMed 25771831
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02246010
- Acronym / sponsor ID
- PED.MN.09
- Conditions
- Acute Gastroenteritis
- Keywords
- diarrhea, developing world, lactose-free diet, Clinical trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very slow recruitment rate. Only 6 infants were recruited over 2 years.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Posted 25 Jan 2019
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 whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.
Detailed description
Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15 % of all childhood death worldwide, and is a major public health burden, especially in developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials reported a modest reduction in the duration of diarrhea in children younger than 5 years who were on reduced or lactose-free diet. Those trials however were conducted on inpatients in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. This study aims at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants from a developing country, who present with acute gastroenteritis to the Emergency Department (ED) or pediatric clinics. The findings from this study will help provide evidence-based dietary recommendations for infants with acute diarrhea in developing countries who are treated in the ambulatory setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactose-free milk | Experimental | Dietary Supplement: Lactose- free milkLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. |
| Regular infant milk | No intervention | –Regular infant milk formula and anti-diarrheic diet for 7 days. |
Who may qualify
- Ages
- 2 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants on artificial milk formula
- Presenting to the ED or pediatric clinics of the American University of Beirut Medical Center
- Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24 hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or without fever, vomiting, mucus or blood per stools).
Key exclusion criteria (2 listed)
- Exclusively or partially breast-fed infants
- Severe dehydration requiring hospitalization
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 milkLactose- free milk | Dietary supplement | Lactose-free milk |
Primary outcome
Diarrhea Duration
Time frame: From onset of illness till the day of last diarrheic stool passed.
number of days with 3 or more loose or watery stools
4 secondary outcomes
Weight Loss
Time frame: 7 days
Illness Visits
Time frame: 7 days
Hospitalization Rate
Time frame: 7 days
Parental Satisfaction
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25771831Nabulsi M, Yazbeck N, Charafeddine F. Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:46. doi: 10.1186/s13063-015-0565-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactose- free milk in people with Acute Gastroenteritis, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 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: stopped early, as of the sponsor's last update on 15 Feb 2019. 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 Lebanon. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diarrhea Duration (time frame: From onset of illness till the day of last diarrheic stool passed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02246010, which also lists 1 linked publication.
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 15 Feb 2019.