Acute diarrhea of probable viral etiology Infections and Infestations
Conditions
Interventions
PRODINFANT study is designed as a multicenter, prospective, randomized, open-label and controlled clinical trial. A cohort of children presenting an acute diarrhea will be randomized between two grou
odd number) or standard supportive measures (control group
even number). All participants regardless of their assigned group receive supportive standard treatment with diet and/or oral rehydration therapy. Children randomized to the synbiotic group receive a
Sponsors
ITF RESEARCH PHARMA S.L.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children from both sex whose parents/guardians have given their informed consent to participate in the study 2. Children aged 2 years or younger who visited the pediatrician in the primary or the emergency healthcare center, presenting an acute diarrhea episode lasting less than 48 hours, with a probable viral origin 3. Children whose diarrhea will be treated only with diet and/or oral rehydration, on an outpatient basis 4. Children for whom the pediatrician considers treatment with the dietary supplement Prodefen GG drops as an additional treatment measure
Exclusion criteria
Exclusion criteria: 1. Children who have presence of any disease that may cause diarrhea, different from an infection, such as inflammatory bowel disease, food allergy, lactose intolerance, etc. 2. Immunocompromised children, children with valve implants, and/or those with a history of infectious endocarditis, due to the risk of bacteremia 3. Children with severe dehydration or malnutrition 4. Children with visible blood in stools 5. Children with current pharmacological treatment for diarrhea 6. Children who have used antibiotics and/or probiotics the previous 7 days 7. Children allergic to milk protein (Prodefen GG drops may contain traces of milk, but do not affect those who are lactose intolerant) 8. Children currently participating in another study 9. Children allergic to any of the components of Prodefen GG drops
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy is measured using the percentage of children who suffer diarrhea according to several definitions, the WHO criteria, the Bristol Stool Form Scale (BSFS) criteria, both WHO and BSFS criteria, and the parents’ opinion regarding more stools per day or more fluid in consistency for at least 1, =2 or =3 consecutive days from day 1 to the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days of diarrhea (three or more passage of stools per day) and duration (days) of diarrhea are measured until the end of the study 2. Recovery is measured by the percentage of children recovered from diarrhea (2 consecutive days without diarrhea) and the stool characteristics (frequency, consistency according to the BSFS, severity of diarrhea) throughout the study 3. Associated symptoms (vomiting, nausea, fever, mucus in stools and abdominal pain) are measured by the duration of symptoms and need of treatment throughout the study 4. Recovery are measured counting the number of visits to the primary care pediatrician or the emergency service as well as the need of concomitant medication throughout the study 5. Tolerability of the synbiotic product and satisfaction with treatment (acceptability) are measured using a 5-point Likert scale, from “very good” to “very bad” and from “very satisfied” to “not at all satisfied”, respectively at week 8 6. The impact of treatment on the quality of life and daily activities of the parents will be assessed using a 5-point Likert scale from “not at all affected” to “extremely affected” at week 4 and 8 | — |
Countries
Spain
Contacts
Public ContactFrancisco Javier Hidalgo Bermejo
Outcome results
None listed