An interventional study of Lactose-free milk formula (Frisolac LF ®) in Acute Gastroenteritis, sponsored by The Women and Children Hospital of An Giang. Recruiting at 1 site in Vietnam. Open to participants aged 2 Months to 24 Months. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by The Women and Children Hospital of An Giang · Not applicable, Interventional, and Treatment
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.
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.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's planned enrollment of 66 is below the median of 136 across 164 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →This is the only study on the registry with The Women and Children Hospital of An Giang as lead sponsor.
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Exclusion Criteria:
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lactose-free milk formula (Frisolac LF ®)
Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)
Regular infant milk formula
Dietary Supplement: 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
Change in diarrhea duration
llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)
Time frame: 7 days
Weight gain
Time frame: 7 days
Severity of diarrhea according to the modified Vesikari score
Time frame: 7 days
Plan to share: Undecided
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