Role of Probiotics in recovery of children with Severe Acute Malnutritio
- Conditions
- Severe acute malnutrition (SAM)Nutritional, Metabolic, EndocrineMalnutrition
- Registration Number
- ISRCTN16454889
- Lead Sponsor
- Chr. Hansen A/S (Denmark)
- Brief Summary
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28079729 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31169661 results (added 10/06/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34140028/ analysis of weight and MUAC gain velocities (added 21/06/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34712895/ Weight-for-Height Z-score Gain (sub study) (added 01/11/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
1. Age 6 - 59 months
2. Children with severe acute malnutrition
3. Care-taker willing to come back for follow-up
4. Written informed consent obtained by parent or care-taker
1. Patients with severe conditions and diseases
1.1. Shock at admission. Once stabilized, these children may be included.
1.2. Severe respiratory difficulty at admission. Once stabilized, these children may be included.
2. Weight below 4 kg at admission
3. Obvious disability, e.g. Cerebral palsy, hydrocephalus, Down?s syndrome
4. Significant congenital diseases, e.g. Congenital heart disease
5. Malignant diseases
6. Patients considered by study staff not to be able to participate in the study
7. Patients being admitted with SAM in the last 6 months
8. Patients participating in another study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measures as of 11/09/2015:<br> Duration of diarrhea during hospitalization<br><br> Previous primary outcome measures:<br> Duration of diarrhea episodes (days)<br>
- Secondary Outcome Measures
Name Time Method