Trial Outcomes & Findings for Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement (NCT NCT01540162)
NCT ID: NCT01540162
Last Updated: 2015-09-10
Results Overview
ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Recruitment status
COMPLETED
Target enrollment
62 participants
Primary outcome timeframe
first 28 days of life
Results posted on
2015-09-10
Participant Flow
Participant milestones
| Measure |
Group I
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
|
Group II
Patients of group II remain unexposed to the probiotic Mutaflor.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
COMPLETED
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
Baseline characteristics by cohort
| Measure |
Group I
n=30 Participants
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
|
Group II
n=32 Participants
Patients of group II remain unexposed to the probiotic Mutaflor.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
30 participants
n=99 Participants
|
32 participants
n=107 Participants
|
62 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: first 28 days of lifeARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Outcome measures
| Measure |
Group I
n=30 Participants
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
|
Group II
n=32 Participants
Patients of group II remain unexposed to the probiotic Mutaflor.
|
|---|---|---|
|
The Number (Rate) of Patients With Acute Respiratory Infections
|
3 participants
|
14 participants
|
SECONDARY outcome
Timeframe: first 6 month of lifeARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Outcome measures
| Measure |
Group I
n=30 Participants
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
|
Group II
n=32 Participants
Patients of group II remain unexposed to the probiotic Mutaflor.
|
|---|---|---|
|
The Number (Rate) of Patients With Acute Respiratory Infections
|
15 participants
|
23 participants
|
SECONDARY outcome
Timeframe: first 12 month of lifeARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Outcome measures
| Measure |
Group I
n=30 Participants
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
|
Group II
n=32 Participants
Patients of group II remain unexposed to the probiotic Mutaflor.
|
|---|---|---|
|
The Number (Rate) of Patients With Acute Respiratory Infections
|
23 participants
|
29 participants
|
Adverse Events
Group I
Serious events: 11 serious events
Other events: 15 other events
Deaths: 0 deaths
Group II
Serious events: 20 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I
n=30 participants at risk
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
|
Group II
n=32 participants at risk
Patients of group II remain unexposed to the probiotic Mutaflor.
|
|---|---|---|
|
Infections and infestations
Acute Respiratory and Gastrointestinal Infections
|
36.7%
11/30 • Number of events 12
|
62.5%
20/32 • Number of events 22
|
Other adverse events
| Measure |
Group I
n=30 participants at risk
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
|
Group II
n=32 participants at risk
Patients of group II remain unexposed to the probiotic Mutaflor.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Infections
|
50.0%
15/30 • Number of events 17
|
68.8%
22/32 • Number of events 24
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
40.0%
12/30 • Number of events 14
|
40.6%
13/32 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
10.0%
3/30 • Number of events 3
|
9.4%
3/32 • Number of events 3
|
|
Blood and lymphatic system disorders
Changed Blood Parameter
|
6.7%
2/30 • Number of events 2
|
9.4%
3/32 • Number of events 4
|
Additional Information
Prof. Mykola L. Aryayev, MD & PhD
National Medical University Odessa
Phone: +380 48 740 5249
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place