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Role of Probiotics in recovery of children with Severe Acute Malnutrition

Role of Probiotics in recovery of children with Severe Acute Malnutrition: a randomized, double-blind, placebo-controlled, parallel study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16454889
Enrollment
400
Registered
2014-01-15
Start date
2014-03-01
Completion date
Unknown
Last updated
2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute malnutrition (SAM) Nutritional, Metabolic, Endocrine Malnutrition

Interventions

Two study arms - receiving one daily dose of: 1. Probiotic sachet containing two probiotic strains (Lactobacillus and Bifidobacterium) 2. Placebo sachet

Sponsors

Chr. Hansen A/S (Denmark)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 11/09/2015: Duration of diarrhea during hospitalization Previous primary outcome measures: Duration of diarrhea episodes (days)

Secondary

MeasureTime frame
Current secondary outcome measures as of 11/09/2015: 1. Incidence and severity of diarrhea (during hospitalization and during the outpatient treatment period, respectively) and duration of diarrhea during the outpatient treatment period 2. Incidence, severity and duration of pneumonia (during hospitalization and during the outpatient treatment period, respectively) 3. Nutritional recovery based on weight gain (during hospitalization and during the outpatient treatment period, respectively) 4. Specific changes in gut microbiota, immune response and intestinal health markers as indicated in the study protocol (at discharge and after 8 weeks outpatient treatment) Diarrhea, pneumonia and weight gain are measured throughout the study. Diarrhea and pneumonia will be measured daily and weight gain will be measured daily during the hospitalization and fortnightly during the follow-up period. We will include all these measurements in the statistical analyses Previous secondary outcome measures: 1. Incidence and severity of diarrhea episodes (during hospitalization and during the outpatient treatment period, respectively) 2. Incidence, severity and duration of pneumonia episodes (during hospitalization and during the outpatient treatment period, respectively) 3. Nutritional recovery based on weight gain (during hospitalization and during the outpatient treatment period, respectively) 4. Specific changes in gut microbiota, immune response and intestinal health markers as indicated in the study protocol (at discharge and after 8 weeks outpatient treatment) Diarrhea, pneumonia and weight gain are measured throughout the study. Diarrhea and pneumonia will be measured daily and weight gain will be measured daily during the hospitalization and fortnightly during the follow-u

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026