Acute Gastroenteritis
Conditions
Keywords
diarrhea, developing world, lactose-free diet, Clinical trial
Brief 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.
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.
Interventions
Lactose- free milk
Sponsors
Study design
Eligibility
Inclusion criteria
* 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).
Exclusion criteria
* Exclusively or partially breast-fed infants * Severe dehydration requiring hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea Duration | From onset of illness till the day of last diarrheic stool passed. | number of days with 3 or more loose or watery stools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 7 days | Percent weight loss from baseline |
| Illness Visits | 7 days | Number of participants with illness visits |
| Hospitalization Rate | 7 days | Rate of hospitalization |
| Parental Satisfaction | 7 days | Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied). |
Countries
Lebanon
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactose-free Milk Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. | 4 |
| Regular Infant Milk Regular infant milk formula and anti-diarrheic diet for 7 days. | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Lactose-free Milk | Regular Infant Milk | Total |
|---|---|---|---|
| Age, Customized Equal or more than 6 months | 3 Participants | 2 Participants | 5 Participants |
| Age, Customized Less than 6 months | 1 Participants | 0 Participants | 1 Participants |
| Diarrhea duration | 4.2 Days STANDARD_DEVIATION 2.2 | 3.5 Days STANDARD_DEVIATION 0.7 | 4.0 Days STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Diarrhea Duration
number of days with 3 or more loose or watery stools
Time frame: From onset of illness till the day of last diarrheic stool passed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactose-free Milk | Diarrhea Duration | 8.7 Days | Standard Deviation 2.2 |
| Regular Infant Milk | Diarrhea Duration | 8.5 Days | Standard Deviation 2.1 |
Hospitalization Rate
Rate of hospitalization
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactose-free Milk | Hospitalization Rate | 0 Participants |
| Regular Infant Milk | Hospitalization Rate | 0 Participants |
Illness Visits
Number of participants with illness visits
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactose-free Milk | Illness Visits | 3 Participants |
| Regular Infant Milk | Illness Visits | 1 Participants |
Parental Satisfaction
Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactose-free Milk | Parental Satisfaction | 7.7 units on a scale | Standard Deviation 0.6 |
| Regular Infant Milk | Parental Satisfaction | 9.5 units on a scale | Standard Deviation 0.7 |
Weight Loss
Percent weight loss from baseline
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactose-free Milk | Weight Loss | 8.6 percent of body weight in kilogram | Standard Deviation 0.2 |
| Regular Infant Milk | Weight Loss | 2.5 percent of body weight in kilogram | Standard Deviation 0.1 |