Acute GastroenteritisNCT05634603
Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants
A study testing Lactose-free milk formula (Frisolac LF ®) in people with Acute Gastroenteritis, run by The Women and Children Hospital of An Giang at 1 site in Vietnam.
Trial summary
The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Lactose-free milk formula (Frisolac LF ®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2022to 30 Apr 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 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 2- 24 months old on artificial milk formula
- Acute diarrhea (3 or more loose or liquid stools per day)
Who cannot join
- Used antibiotics within 3 days before admission
- Breastfeeding
- Severe dehydration, defined by a need of IV rehydration
- Malnutrition (weight/height< -3SD)
- Chronic underlying disease, immunocompromised condition or systemic infection
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Can Tho Children Hospital
Can Tho, 0292
Diep Ngoc Thai, doctor, 0775838622 ext. 084, ngocdiepthai41@gmail.com
Rang Ngoc Nguyen, Ph D, 0913106404 ext. 084, nguyenngocrang@gmail.com
About this study
Official title: Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial
The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.
Read the detailed description
More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.
- Conditions
- Acute Gastroenteritis
- Being tested
- Lactose-free milk formula (Frisolac LF ®)
- Keywords
- diarrhea lactose-free diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose-free milk formula (Frisolac LF ®)Dietary supplement
Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Lactose-free milk formula (Frisolac LF ®) Receives: Dietary Supplement: Lactose-free milk formula (Frisolac LF ®) |
| Placebo | Placebo comparator | Regular infant milk formula Receives: Dietary Supplement: Lactose-free milk formula (Frisolac LF ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diarrhea duration
llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)
Measured: 7 days
Secondary outcomes (2)
Weight gain
Measured: 7 days
Severity of diarrhea according to the modified Vesikari score
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 posted2 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Women and Children Hospital of An Giang
- Sponsor type
- University, hospital or other
- Collaborators
- Can Tho University of Medicine and Pharmacy
- Responsible party
- Principal investigator, Rang Nguyen, The Women and Children Hospital of An Giang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634603
- Sponsor's protocol ID
- WCHAnGiang
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
MacGillivray S, Fahey T, McGuire W. Lactose avoidance for young children with acute diarrhoea. Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2.
PubMed 24173771Simakachorn N, Tongpenyai Y, Tongtan O, Varavithya W. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. J Med Assoc Thai. 2004 Jun;87(6):641-9.
PubMed 15279342
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05634603
- Acronym / sponsor ID
- WCHAnGiang
- Conditions
- Acute Gastroenteritis
- Keywords
- diarrhea lactose-free diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Women and Children Hospital of An GiangUniversity, hospital or other
- Collaborators
- Can Tho University of Medicine and Pharmacy
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 2 Dec 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.
The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.
Detailed description
More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)Lactose-free milk formula (Frisolac LF ®) |
| Placebo | Placebo comparator | Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)Regular infant milk formula |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 2- 24 months old on artificial milk formula
- Acute diarrhea (3 or more loose or liquid stools per day)
Key exclusion criteria (5 listed)
- Used antibiotics within 3 days before admission
- Breastfeeding
- Severe dehydration, defined by a need of IV rehydration
- Malnutrition (weight/height< -3SD)
- Chronic underlying disease, immunocompromised condition or systemic infection
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 milk formula (Frisolac LF ®)Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula | Dietary supplement | Intervention, Placebo |
Primary outcome
Change in diarrhea duration
Time frame: 7 days
llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)
2 secondary outcomes
Weight gain
Time frame: 7 days
Severity of diarrhea according to the modified Vesikari score
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Results publication: PubMed 24173771MacGillivray S, Fahey T, McGuire W. Lactose avoidance for young children with acute diarrhoea. Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2.
- Results publication: PubMed 15279342Simakachorn N, Tongpenyai Y, Tongtan O, Varavithya W. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. J Med Assoc Thai. 2004 Jun;87(6):641-9.
- Individual participant dataSharing planned: Undecided
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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.
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 formula (Frisolac LF ®) in people with Acute Gastroenteritis, run by The Women and Children Hospital of An Giang at 1 site in Vietnam.
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 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 2 Dec 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 Vietnam. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diarrhea duration (time frame: 7 days). 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 NCT05634603, which also lists 2 linked publications.
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 2 Dec 2022; AzTrials last refreshed its copy on 26 Oct 2026.