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NCT03154866
Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
Phase 4 trial testing Lactobacillus kefiri LKF01 DSM32079 in Caesarean Section;Stillbirth in 60 participants. Status unknown.
31 December 2017
Quick facts
| Lead sponsor | Policlinico Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 June 2017 |
| Primary completion | 31 December 2017 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Lactobacillus kefiri LKF01 DSM32079
- Placebo
Conditions studied
- Caesarean Section;Stillbirth — all drugs for Caesarean Section;Stillbirth →
- Microbial Colonization — all drugs for Microbial Colonization →
Sponsor
Policlinico Hospital
Who can join
Adults 1 Hour to 4 Months, any sex, with Caesarean Section;Stillbirth or Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life. Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03154866
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03154866 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Policlinico Hospital
- Last refreshed: 18 May 2017
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