AzTrials
AzTrials

Neonatal SepsisPhase 3ProRIDENCT04172012

Use of Probiotics to Reduce Infections, Death and ESBL Colonisation

A Phase 3 study testing Labinic (R) probiotic mixture in people with Neonatal Sepsis, run by Haydom Lutheran Hospital at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 3 daysHealthy volunteers can take part
Conditions the study is for
Neonatal Sepsis
What is being tested?
Labinic (R) probiotic mixture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
1 siteTanzania
Study dates
1 Feb 2022to 19 Sep 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Birth weight below 2 kg
  • Other health problems/illness, obvious congenital malformations.
  • Multiple pregnancy
  • Parents not consenting

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Haydom Lutheran Hospital

    Babati, Manyara Region

Other trials in Tanzania

About this study

Official title: 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

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.

Read the 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, severe infections such as sepsis may be prevented, and thereby survival may be improved.

Conditions
Neonatal Sepsis
Being tested
Labinic (R) probiotic mixture, Placebo
Keywords
Tanzania, East Africa, Antimicrobial resistance, Probiotics, Extended Spectrum Beta-Lactamase Producing Bacteria
Medical subject headings
Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Labinic (R) probiotic mixtureBiological

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

  • PlaceboOther

    Placebo mixture

Study groups in NCT04172012
Study groupRoleWhat they receive
ProbioticActive comparatorStudy subjects receive probiotic mixture for 4 weeks
Receives: Biological: Labinic (R) probiotic mixture
PlaceboPlacebo comparatorStudy subjects receive placebo mixture for 4 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome hospitalization and death

    Primary outcome is hospitalization and/or death of study subject

    Measured: 6 months from inclusion

Secondary outcomes (12)

  1. ESBL colonization

    Faecal colonisation with Extended-spectrum beta-lactamase-producing Enterobacteriaceae as detected by fecal swab

    Measured: 6 weeks and 6 months

  2. Hospitalisation

    Hospitalisation

    Measured: 6 weeks and 6 months

  3. Death

    Death during study period

    Measured: 6 months

  4. Body weight

    Growth monitored by weight

    Measured: 6 months

  5. Body length

    Growth monitored by length

    Measured: 6 months

  6. Stool microbiota

    Stool microbiota composition including resistome analysis (metagenome sequencing)

    Measured: 6 weeks and 6 months

  7. Stool metabolome

    Stool metabolome composition

    Measured: 6 weeks and 6 months

  8. Stool inflammatory markers - Calprotectin

    Levels of Calprotectin in participants' stool samples

    Measured: 6 weeks and 6 months

  9. Stool inflammatory markers - alpha-1 antitrypsin

    Levels of alpha-1 antitrypsin (AAT) in participants' stool samples

    Measured: 6 weeks and 6 months

  10. Stool inflammatory markers - myeloperoxidase

    Levels of human myeloperoxidase (MPO) in participants' stool samples

    Measured: 6 weeks and 6 months

  11. Number of participants with culture-confirmed bacteremia

    Bacteremia confirmed by blood culture

    Measured: 6 months

  12. Genetic characteristics of ESBL-producing Enterobacteriaceae

    Genetic characteristics of ESBL-E from colonization and clinical samples (targeted screening)

    Measured: 6 weeks and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start1 Feb 2022
  3. Primary completion10 Jul 2023
  4. Study completion19 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Placebo-controlled double-blinded randomized clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172012
Sponsor's protocol ID
2019/1025
Acronym
ProRIDE
Status last verified
Apr 2025
First submitted
19 Nov 2019
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Panigrahi P, Parida S, Nanda NC, Satpathy R, Pradhan L, Chandel DS, Baccaglini L, Mohapatra A, Mohapatra SS, Misra PR, Chaudhry R, Chen HH, Johnson JA, Morris JG, Paneth N, Gewolb IH. A randomized synbiotic trial to prevent sepsis among infants in rural India. Nature. 2017 Aug 24;548(7668):407-412. doi: 10.1038/nature23480. Epub 2017 Aug 16.

    PubMed 28813414

  • Esaiassen E, Hjerde E, Cavanagh JP, Pedersen T, Andresen JH, Rettedal SI, Stoen R, Nakstad B, Willassen NP, Klingenberg C. Effects of Probiotic Supplementation on the Gut Microbiota and Antibiotic Resistome Development in Preterm Infants. Front Pediatr. 2018 Nov 16;6:347. doi: 10.3389/fped.2018.00347. eCollection 2018.

    PubMed 30505830

  • Tellevik MG, Blomberg B, Kommedal O, Maselle SY, Langeland N, Moyo SJ. High Prevalence of Faecal Carriage of ESBL-Producing Enterobacteriaceae among Children in Dar es Salaam, Tanzania. PLoS One. 2016 Dec 9;11(12):e0168024. doi: 10.1371/journal.pone.0168024. eCollection 2016.

    PubMed 27936054

  • Moyo SJ, Justine M, Blomberg B, Lohr IH, Gideon J, Mdoe P, Mduma E, Manyahi J, Pettersen VK, Paschal J, Syre H, Bukhay R, Klingenberg C, Langeland N. Navigating the trials of a trial: lessons from ProRIDE on recruitment, retention, and follow-up in rural Africa. Trials. 2026 Jan 15;27(1):125. doi: 10.1186/s13063-026-09447-3.

    PubMed 41535953

  • Klingenberg C, Justine M, Moyo SJ, Lohr IH, Gideon J, Mdoe P, Mduma E, Manyahi J, Bargheet A, Pettersen VK, Paschal J, Syre H, Bernhoff E, Bukhay R, Blomberg B, Langeland N. Home administration of a multistrain probiotic once per day for 4 weeks to newborn infants in Tanzania (ProRIDE): a double-blind, placebo-controlled randomised trial. Lancet Glob Health. 2025 Jun;13(6):e1082-e1090. doi: 10.1016/S2214-109X(25)00064-6.

    PubMed 40412397

  • Kuwelker K, Langeland N, Lohr IH, Gidion J, Manyahi J, Moyo SJ, Blomberg B, Klingenberg C. Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial. Trials. 2021 Apr 29;22(1):312. doi: 10.1186/s13063-021-05251-3.

    PubMed 33926519

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Labinic (R) probiotic mixture in people with Neonatal Sepsis, run by Haydom Lutheran Hospital at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome hospitalization and death (time frame: 6 months from inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172012, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in