Does probiotic treatment to newborns born with a low birth weight decrease the risk of severe disease in the first 6 months of life?

Probiotic treatment versus placebo to low birth weight neonates for prevention of mortality or undernutrition: two-arm multi-center superiority randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202309763146420

Enrollment

1500

Registered

2023-09-28

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

sepsis Neonatal Diseases Nutritional, Metabolic, Endocrine

Interventions

Probiotics

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Age 1-7 days old 2. Low birth weight defined as birth weight 1000-2499 g as measured on the birth chart. 3. Born at one of the study health facilities, 4. A written informed consent by the mother 5. Agree to complete the planned follow up visits 6. Permanent residents in the defined catchment area

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Infants admitted with severe diseases in need of urgent medical intervention or referral due to the latter severity upon screening. 2. Infant has signs of PSBI upon screening. 3. Infants with major congenital malformations 4. No information on birth weight 5. Infants who weigh more than 2600g on inclusion day when weighed by the study nurse. 6. Severely ill or dead mother

Design outcomes

Primary

Measure	Time frame
Composite outcome of infant mortality (death <12 months of age) and hospitalisation for severe infection/septicemia before 6 months of age.	—

Secondary

Measure	Time frame
• Rates of undernutrition will be determined at follow up visits where weight, height and head circumference of the participant will be registered. Undernutrition is divided into different sub-groups based on anthropometry data, stunting (low height-for-age), underweight (low weight-for-age) and wasting (low weight-for-height). • Rates (%) of episodes of morbidities (in particular septicemia/severe infection) among participants receiving probiotics or placebo • Rates (%) of episodes of death before 24 months of age ? Feasibility of the intervention is defined by adherence to the prescribed intervention dietary supplement. Adherence is defined as =5 out of 28 daily doses missed and the proportion of patients adhering to the prescribed regimen will be determined [33]. ? Postnatal growth (g/kg/day increase) among groups receiving probiotics or placebo in the first 2 years of life. ? Growth monitored by length, weight and head circumference up to 24 months of age. ? Fecal Microbiome composition and diversity among groups receiving probiotics or placebo at 3, 6 and 12 months of age	—

Measure

Time frame

• Rates of undernutrition will be determined at follow up visits where weight, height and head circumference of the participant will be registered. Undernutrition is divided into different sub-groups based on anthropometry data, stunting (low height-for-age), underweight (low weight-for-age) and wasting (low weight-for-height). • Rates (%) of episodes of morbidities (in particular septicemia/severe infection) among participants receiving probiotics or placebo • Rates (%) of episodes of death before 24 months of age ? Feasibility of the intervention is defined by adherence to the prescribed intervention dietary supplement. Adherence is defined as =5 out of 28 daily doses missed and the proportion of patients adhering to the prescribed regimen will be determined [33]. ? Postnatal growth (g/kg/day increase) among groups receiving probiotics or placebo in the first 2 years of life. ? Growth monitored by length, weight and head circumference up to 24 months of age. ? Fecal Microbiome composition and diversity among groups receiving probiotics or placebo at 3, 6 and 12 months of age

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Countries

Rwanda

Contacts

Public ContactRichard Kalisa

senior lecturer

kalichard@gmail.com+4631786000

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026