Trial Outcomes & Findings for Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics (NCT NCT02245815)
NCT ID: NCT02245815
Last Updated: 2021-01-28
Results Overview
(NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
3 weeks
Results posted on
2021-01-28
Participant Flow
clinic
Participant milestones
| Measure |
Use Probiotics Boucardii
group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
use probiotics Boucardii: group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment.
|
Use Probiotics Multi-species
Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
use probiotics Multi-species: Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics
Baseline characteristics by cohort
| Measure |
Use Probiotics Boucardii
n=45 Participants
group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
use probiotics Boucardii: group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment.
|
Use Probiotics Multi-species
n=45 Participants
Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
use probiotics Multi-species: Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.3 weeks of gestation
STANDARD_DEVIATION 1.83 • n=5 Participants
|
31.1 weeks of gestation
STANDARD_DEVIATION 2.3 • n=7 Participants
|
30.7 weeks of gestation
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks(NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III
Outcome measures
| Measure |
Probiotics Lactobacillus Acidophilus Boucardii
n=45 Participants
group A will be administered the Lactobacillus acidophilus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
|
Use Probiotics Multi-species
n=45 Participants
Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
|
|---|---|---|
|
Number of Patients With (NEC)
|
0 participants
|
1 participants
|
POST_HOC outcome
Timeframe: 3 weeksThe change was calculated from two time points (at 3 weeks of treatment minus baseline).
Outcome measures
| Measure |
Probiotics Lactobacillus Acidophilus Boucardii
n=45 Participants
group A will be administered the Lactobacillus acidophilus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
|
Use Probiotics Multi-species
n=45 Participants
Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
|
|---|---|---|
|
Change in Fecal Secretory IgA Levels From Baseline to 3 Weeks of Probiotics Use.
|
0.3 mg/10g
Interval 0.15 to 0.45
|
0.56 mg/10g
Interval 0.24 to 0.89
|
Adverse Events
Use Probiotics Lactobacillus Acidophilus Boucardii
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Use Probiotics Multi-species
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dra. Guadalupe Gómez Rodríguez
Instituto Mexicano del Seguro Social
Phone: 477 75 23 166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place