Acute DiarrheaNCT04796480
Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea
A study testing YOGURT and LACTOSE FREE FORMULA MILK in people with Acute Diarrhea, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
This study was aimed to look at the effect of lactose free formula milk in comparison with home-made plain yogurt in children with acute watery diarrhea. Read more about this study
- Who is it for?
- Ages 4 to 24 months
- Conditions the study is for
- Acute Diarrhea
- What is being tested?
- YOGURT and LACTOSE FREE FORMULA MILK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2018to 9 Dec 2018
- 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 4 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age 4-24 months presenting with acute diarrhea
- Both gender
Who cannot join
- Children on antibiotic therapy within 48 hours prior to presentation
- Malnourished children (-2SD as per WHO criteria)
- Children with severe dehydration requiring IV fluids
- Children < 4 months of age (as weaning not started yet)
Trial locations and contacts
1 site in 1 country.
About this study
This study was aimed to look at the effect of lactose free formula milk in comparison with home-made plain yogurt in children with acute watery diarrhea.
Read the detailed description
A randomized controlled trial using non probability consecutive sampling was carried out on 60 children (30 in each group) in Department of Paediatrics Unit I, Services Hospital Lahore. An informed written consent was taken from parents of the children. Ethical issues considered and maintained throughout the study. Then all children were randomly divided in two groups by using lottery method. In group 1; children were given yogurt while in group 2, children were given lactose free formula milk. In both groups, feed was given 5-8 times per day. Patients were followed-up till resolution of symptoms and discharge from hospital.
- Conditions
- Acute Diarrhea
- Being tested
- YOGURT, LACTOSE FREE FORMULA MILK
- Keywords
- LACTOSE FREE FORMULA MILK, YOGURT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YOGURTDietary supplement
Group 1 was given yogurt
LACTOSE FREE FORMULA MILKDietary supplement
Group 2 was given lactose free formula milk
| Study group | Role | What they receive |
|---|---|---|
| YOGURT | Active comparator | Group 1 children were given home made plain yogurt in treatment of acute diarrhea Receives: Dietary Supplement: YOGURT |
| LACTOSE FREE FORMULA MILK | Active comparator | Group 2 children were given lactose free formula milk in treatment of acute diarrhea Receives: Dietary Supplement: LACTOSE FREE FORMULA MILK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of home-made yogurt versus lactose-free milk on mean duration of diarrhea in children with acute diarrhea
The effect of home-made yogurt and lactose-free milk in children with acute diarrhea was compared i.e. to check out which one is more suitable to treat diarrhea by measuring the mean duration of diarrhea in hours. The reason behind the effectiveness of yogurt against lactose-free milk is the presence of probiotics within it, which help in recovering of good bacteria population in intestine and so may help in decreasing duration and severity of diarrhea.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start10 Jun 2018
- Primary completion9 Dec 2018
- Study completion9 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were divided in 2 groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Mahjabeen Akram, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796480
- Sponsor's protocol ID
- HOSPITAL
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kosek M, Bern C, Guerrant RL. The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Organ. 2003;81(3):197-204. Epub 2003 May 16.
PubMed 12764516Chu C, Rotondo-Trivette S, Michail S. Chronic diarrhea. Curr Probl Pediatr Adolesc Health Care. 2020 Aug;50(8):100841. doi: 10.1016/j.cppeds.2020.100841. Epub 2020 Aug 27.
PubMed 32863166Forster CS, Hsieh MH, Cabana MD. Perspectives from the Society for Pediatric Research: Probiotic use in urinary tract infections, atopic dermatitis, and antibiotic-associated diarrhea: an overview. Pediatr Res. 2021 Aug;90(2):315-327. doi: 10.1038/s41390-020-01298-1. Epub 2020 Dec 7.
PubMed 33288875
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea
- ClinicalTrials.gov ID
- NCT04796480
- Acronym / sponsor ID
- HOSPITAL
- Conditions
- Acute Diarrhea
- Keywords
- LACTOSE FREE FORMULA MILK, YOGURT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 9 Dec 2018 (actual)
- Study completion
- 9 Dec 2018 (actual)
- First posted
- 15 Mar 2021 (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.
This study was aimed to look at the effect of lactose free formula milk in comparison with home-made plain yogurt in children with acute watery diarrhea.
Detailed description
A randomized controlled trial using non probability consecutive sampling was carried out on 60 children (30 in each group) in Department of Paediatrics Unit I, Services Hospital Lahore. An informed written consent was taken from parents of the children. Ethical issues considered and maintained throughout the study. Then all children were randomly divided in two groups by using lottery method. In group 1; children were given yogurt while in group 2, children were given lactose free formula milk. In both groups, feed was given 5-8 times per day. Patients were followed-up till resolution of symptoms and discharge from hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were divided in 2 groups.
| Arm | Type | Receives |
|---|---|---|
| YOGURT | Active comparator | Dietary Supplement: YOGURTGroup 1 children were given home made plain yogurt in treatment of acute diarrhea |
| LACTOSE FREE FORMULA MILK | Active comparator | Dietary Supplement: LACTOSE FREE FORMULA MILKGroup 2 children were given lactose free formula milk in treatment of acute diarrhea |
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of age 4-24 months presenting with acute diarrhea
- Both gender
Key exclusion criteria (4 listed)
- Children on antibiotic therapy within 48 hours prior to presentation
- Malnourished children (-2SD as per WHO criteria)
- Children with severe dehydration requiring IV fluids
- Children < 4 months of age (as weaning not started yet)
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 |
|---|---|---|
| YOGURTGroup 1 was given yogurt | Dietary supplement | YOGURT |
| LACTOSE FREE FORMULA MILKGroup 2 was given lactose free formula milk | Dietary supplement | LACTOSE FREE FORMULA MILK |
Primary outcome
Effect of home-made yogurt versus lactose-free milk on mean duration of diarrhea in children with acute diarrhea
Time frame: 6 Months
The effect of home-made yogurt and lactose-free milk in children with acute diarrhea was compared i.e. to check out which one is more suitable to treat diarrhea by measuring the mean duration of diarrhea in hours. The reason behind the effectiveness of yogurt against lactose-free milk is the presence of probiotics within it, which help in recovering of good bacteria population in intestine and so may help in decreasing duration and severity of diarrhea.
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 16 Mar 2021.
- Background: PubMed 12764516Kosek M, Bern C, Guerrant RL. The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Organ. 2003;81(3):197-204. Epub 2003 May 16.
- Background: PubMed 32863166Chu C, Rotondo-Trivette S, Michail S. Chronic diarrhea. Curr Probl Pediatr Adolesc Health Care. 2020 Aug;50(8):100841. doi: 10.1016/j.cppeds.2020.100841. Epub 2020 Aug 27.
- Background: PubMed 33288875Forster CS, Hsieh MH, Cabana MD. Perspectives from the Society for Pediatric Research: Probiotic use in urinary tract infections, atopic dermatitis, and antibiotic-associated diarrhea: an overview. Pediatr Res. 2021 Aug;90(2):315-327. doi: 10.1038/s41390-020-01298-1. Epub 2020 Dec 7.
- Individual participant dataSharing planned: No
Related trials for Acute 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
Not yet recruiting
Rural Water Filtration and Health Study
Diarrhea, Enteric Pathogens
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 YOGURT and LACTOSE FREE FORMULA MILK in people with Acute Diarrhea, run by Services 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?
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 16 Mar 2021. 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. 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?
Effect of home-made yogurt versus lactose-free milk on mean duration of diarrhea in children with acute diarrhea (time frame: 6 Months). 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 NCT04796480, which also lists 3 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 16 Mar 2021.