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NCT03663556: FEEDMI
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
trial testing Infant-feeding in Very Preterm Infants in 60 participants. Status unknown.
30 December 2018
Quick facts
| Lead sponsor | Universidade do Porto |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 25 May 2017 |
| Primary completion | 30 December 2018 |
| Estimated completion | 30 December 2018 |
| Sites | 2 locations across Portugal |
Drugs / interventions tested
- Infant-feeding
Conditions studied
- Very Preterm Infants — all drugs for Very Preterm Infants →
Sponsor
Universidade do Porto — full company profile →
Who can join
Under 2 Days, any sex, with Very Preterm Infants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse. Several factors may influence infants' microbiota such as mother's diet, mode of delivery, antibiotic exposure and type of feeding. The main goal of this observational study is to evaluate the impact of different types of feeding (breast milk, donor human milk and preterm formulas) on the intestinal microbiota of preterm infants hospitalized in the neonatal intensive care unit (NICU) of Maternidade Alfredo da Costa (MAC). Furthermore, the influence of mode of delivery and the mother's diet, among others factors, on vertical microbiota transmission will be evaluated. After delivery, mothers will be asked to collect their own fecal samples and will be invited to complete a semi-quantitative food frequency questionnaire. Stool samples will be collected from premature infants every 7 days. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Extremely preterm neonates have more <i>Lactobacillus</i> in meconium than very preterm neonates - the <i>in utero</i> microbial colonization hypothesis.
Morais J, Marques C, Teixeira D, Durão C, et al · · 2020 · cited 15× · PMID 32658601 · DOI 10.1080/19490976.2020.1785804 -
Influence of Human Milk on Very Preterms' Gut Microbiota and Alkaline Phosphatase Activity.
Morais J, Marques C, Faria A, Teixeira D, et al · · 2021 · cited 14× · PMID 34066473 · DOI 10.3390/nu13051564
Verify or expand the search:
- PubMed search for NCT03663556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
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Currently open trials in the same condition.
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Other Universidade do Porto trials
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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 NCT03663556 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade do Porto
- Last refreshed: 2 October 2018
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/NCT03663556.
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