Use of Probiotics to Reduce Infections, Death and ESBL Colonisation

Use of Probiotics to Reduce Infections and Death and Prevent Colonization With Extended-spectrum Beta-lactamase Producing Bacteria, Among Newborn Infants in Haydom and Surrounding Area, Tanzania, a Randomized Controlled Clinical Trial

Sponsors

Lead Sponsor: University of Bergen

Collaborator: Haydom Lutheran Hospital
Helse Stavanger HF
UiT The Arctic University of Norway
Muhimbili University of Health and Allied Sciences

Source University of Bergen
Brief Summary

This study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with Extended-spectrum beta-lactamase-producing Gram negative bacteria. Half of the babies will receive 4 weeks treatment with an oral mixture of the probiotic Labinic (R) while the other half will receive a placebo mixture.

Detailed Description

Studies show that probiotics given to prematurely born babies prevents sepsis and is widely used in the western world for this purpose. Probiotics consists of one or more normal gut-bacteria. A large study in India showed that giving probiotics to full-born babies reduced hospitalizations and morbidity. This study investigates giving a probiotic mixture with different combination of bacteria, Lactobacillus acidophilus, Bifidobacterium infantis and Bifidobacterium breve, for a longer duration (4 weeks instead of 7 days).

Infections with antibiotic-resistant bacteria is a major threat to health-care world-wide, and sepsis/severe infection caused by such bacteria is a major cause of neonatal death. The study hypothesis is that giving probiotics to newborns prevents them from getting colonized with antibiotic-resistant bacteria, such as Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE). By preventing colonization with ESBL-PE, we may prevent severe infections such as sepsis, and thereby also prevent death.

Overall Status Not yet recruiting
Start Date March 1, 2020
Completion Date September 1, 2021
Primary Completion Date September 1, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Composite outcome hospitalization and death 6 months from inclusion
Secondary Outcome
Measure Time Frame
ESBL colonization 6 months
Enrollment 2000
Condition
Intervention

Intervention Type: Biological

Intervention Name: Labinic (R) probiotic mixture

Description: Labinic (R) probiotic mixture containing Lactobacillus acidophilus and Bifidobacterium infantis and B. breve

Arm Group Label: Probiotic

Intervention Type: Other

Intervention Name: Placebo

Description: Placebo mixture

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Healthy newborn infants with a birth weight equal or above 2.0 kgs, will be included in the study between 0-3 days of life.

- Newborn infants have to come from families who are long-term or permanent residents in the defined catchment area for this trial (30 km radius from HLH) in Tanzania.

- Parents are able and willing to complete study visit (including required study procedures) schedules over the six months proposed follow-up, which also includes hospitalizations required for compliance of this study protocol.

- Parents agrees for the child not to participate in another study during the study period

- Children less than one year admitted to hospital with suspected infection, not included in the RCT, will be included in a sub-study. A separate inclusion form is prepared for these children.

Exclusion Criteria:

- Birth weight below 2 kg

- Other health problems/illness, obvious congenital malformations.

- Parents not consenting

Gender: All

Minimum Age: N/A

Maximum Age: 3 Days

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Nina Langeland, MD, PhD Principal Investigator University of Bergen
Overall Contact

Last Name: Nina Langeland, MD, PhD

Phone: +4741616450

Email: [email protected]

Location
Facility: Contact: Haydom Lutheran Hospital Joshua G Gidabayda, MD, MMed +255784995669 [email protected]
Location Countries

Tanzania

Verification Date

November 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Probiotic

Type: Active Comparator

Description: Study subjects receive probiotic mixture for 4 weeks

Label: Placebo

Type: Placebo Comparator

Description: Study subjects receive placebo mixture for 4 weeks

Acronym ProRIDE
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Placebo-controlled double-blinded randomized clinical trial

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Investigational product (probiotic) and placebo product have both been produced by the same manufacturer and is delivered in identical bottles.

Source: ClinicalTrials.gov