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NCT03675048
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
NA trial testing BioGaia Protectis drops in Dysbiosis in 97 participants. Completed in 15 December 2020.
5 October 2020
Quick facts
| Lead sponsor | BioGaia AB |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 97 |
| Start date | 1 October 2018 |
| Primary completion | 5 October 2020 |
| Estimated completion | 15 December 2020 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- BioGaia Protectis drops
- Placebo
Conditions studied
- Dysbiosis — all drugs for Dysbiosis →
- Prophylaxis — all drugs for Prophylaxis →
Sponsor
BioGaia AB — full company profile →
Who can join
Adults 0 Hours to 48 Hours, any sex, with Dysbiosis or Prophylaxis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section. It is anticipated that daily using of probiotic Lactobacillus reuteri DSM 17938 can prevent development of early dysbiosis of gut microbiota induced by Caesarean section.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03675048
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dysbiosis
Currently open trials in the same condition.
- NCT07148583 — BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months · NA · recruiting
- NCT07231003 — The Effect of Glucomannan Powder on Improving Gut Microbiota. · NA · active not recruiting
- NCT06877585 — Association Between Fecal Microbiota Composition, Metabolite Concentrations, and Indoxyl Sulfate Levels · recruiting
- NCT06872320 — The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease · NA · active not recruiting
- NCT06914375 — Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health · NA · active not recruiting
Other BioGaia AB trials
Trials by the same sponsor.
- NCT07190859 — Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With C · NA · recruiting
- NCT06462651 — Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic · NA · completed
- NCT05512234 — Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic · NA · recruiting
- NCT05044949 — Study Evaluating the Safety and Tolerability of a Probioitc · NA · completed
- NCT04692506 — Study Evaluating the Safety and Tolerability · NA · completed
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 NCT03675048 (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 BioGaia AB
- Last refreshed: 20 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03675048.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing