Digestive System
Conditions
Interventions
Single Strain Probiotics SB Cohort A Arm 1
Placebo plus standard of care of ORS and Zinc
Single Strain Probiotic LGG Cohort A Arm 2
Multistrain of Probiotics . Cohort B Arm 1
Placebo with ORS and Zinc for children with severe acut malnutrition Cohor B Arm 2
Sponsors
Pending Grant application
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort A: General Population Protocol • Age 6 to 59 months. • Acute infectious diarrhoea is defined by strict WHO criteria ( 3 loose/watery stools in a 24-hour period). • Duration of diarrhoeal symptoms -3 standard deviations (SD). Cohort B: Severe Acute Malnutrition (SAM) Protocol •Age 6 to 59 months. • Formal diagnosis of SAM defined by WHO criteria: weight-for-height z-score < -3 SD, mid-upper arm circumference (MUAC) <115 mm, or the presence of bilateral pitting nutritional oedema. • Acute diarrhoea meeting WHO criteria. • Formal admission to either inpatient stabilization or outpatient therapeutic care programs.
Exclusion criteria
Exclusion criteria: Cohort A: General Population Protocol • Bloody diarrhoea (dysentery) suggestive of invasive bacterial pathogens requiring specific targeted antibiotics. • Severe dehydration with hypovolemic shock requiring immediate intravenous (IV) fluid resuscitation. • Current use of systemic antibiotics or previous use of any probiotic supplement within the preceding 14 days. • Known underlying primary immunodeficiency, HIV infection (unless virally suppressed), or chronic inflammatory gastrointestinal pathology. Cohort B: Severe Acute Malnutrition (SAM) Protocol • Refractory septic shock requiring vasopressor support. • Known anatomical gastrointestinal anomalies or previous bowel resection. • Prior probiotic use within the preceding 14 days. • Absolute inability to tolerate enteral feeding or oral rehydration therapies, necessitating exclusive parenteral nutrition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome for both Cohort A and the efficacy branch of Cohort B is the total continuous duration of diarrhoea, measured in precise hours. The temporal onset refers to the precise moment when the initial dose of the investigational substance (or placebo) is given. ;Primary Safety Outcomes (Specifically for Cohort B - SAM): The total number of severe adverse events, specifically the emergence of culture-confirmed probiotic-associated systemic infections. This refers to the isolation of a Lactobacillus and Saccharomyces species from a sterile site (e.g., peripheral blood culture or cerebrospinal fluid). Any instance of rapidly deteriorating clinical status resulting in unanticipated intensive care admission, or occurrences of inpatient or post-discharge mortality, will be continuously documented and necessitate immediate evaluation by the DSMB. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool Frequency and Consistency: The average number of diarrhoeal stools passed on day two (48 hours after the start of the intervention) and the qualitative change in stool consistency. Risk of Prolonged Diarrhoea: The estimated relative risk of the acute diarrhoeal episode lasting more than 48 hours following intervention. Hospitalisation Duration: The total number of days spent in the hospital, measured in absolute days, for individuals whose severity required them to be admitted to the hospital. Symptomatic Clearance: The duration necessary for the persistent alleviation of related systemic symptoms, particularly the cessation of vomiting and the normalisation of increased core body temperature. | — |
Countries
Nigeria
Contacts
Public ContactAdanze Asinobi
Professor at the University of Ibadan
Outcome results
None listed