E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
necrotising enterocolitis (NEC |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014878 |
E.1.2 | Term | Enteritis necroticans |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate the effects of oral supplementation with a probiotic (Lactobacillus reuteri) on the reduction of the incidence rate of NEC stage  II in VLBW infants. |
|
E.2.2 | Secondary objectives of the trial |
: to evaluate the efficacy and security of this probiotic, by the subsequent data: 1. gut colonization by pathogenic bacteria 2. rate of nosocomial infections 3. security of oral supplementation with this probiotic in preterm infants (rate of sepsis caused by L. reuteri) 4. feeding tolerance (days needed to reach total enteral nutrition) 5. growth 6. rate of fat absorption in the gut 7. length of CVC stay (days) 8. length of total/partial parenteral nutrition (days) 9. length of the hospital stay (days) 10. death (all causes) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) birth weight < 1500 gr (VLBW infants) 2) infants from 1 to 4 days-old 3) written informed consent signed by each infants parents |
|
E.4 | Principal exclusion criteria |
EXCLUSION CRITERIA : 1) anatomic gastrointestinal malformations 2) major congenital malformations 3) severe clinical conditions that, according to the researcher judgement, do not indicate the inclusion in the study 4) patients unable to follow the study protocol and to sign written informed consent. The consent must be signed also by parents/guardian or by the legal representative, if patients are underage or unable to give their consent. Underage patients and patients unable to give consent must sign the consent in so far as they can. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
to evaluate the effects of oral supplementation with a probiotic (Lactobacillus reuteri) on the reduction of the incidence rate of NEC stage  II in VLBW infants. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |