Trial Outcomes & Findings for The Efficacy of Symbiotic on Cytokines (NCT NCT01899677)
NCT ID: NCT01899677
Last Updated: 2014-08-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
70 participants
Primary outcome timeframe
0+2 day
Results posted on
2014-08-08
Participant Flow
Participant milestones
| Measure |
Symbiotic
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
25
|
28
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of Symbiotic on Cytokines
Baseline characteristics by cohort
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 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
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
birth weight
|
1266 grams
STANDARD_DEVIATION 228 • n=5 Participants
|
1230 grams
STANDARD_DEVIATION 262 • n=7 Participants
|
1245 grams
STANDARD_DEVIATION 247 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0+2 dayOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 5 Serum Cytokine Level on 0+2 Day
|
4 pg/ml
Interval 2.5 to 5.5
|
4 pg/ml
Interval 2.0 to 4.0
|
PRIMARY outcome
Timeframe: 14+/-2 dayOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 5 Levels on 14+/-2 Day
|
4 pg/ml
Interval 2.5 to 7.5
|
4 pg/ml
Interval 2.2 to 11.2
|
PRIMARY outcome
Timeframe: 28+/-2 dayOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 5 Levels at 28+/-2 Day
|
3 pg/ml
Interval 1.0 to 4.0
|
3 pg/ml
Interval 2.2 to 4.0
|
PRIMARY outcome
Timeframe: 0+2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 10 Levels at 0+2 Days
|
13 pg/ml
Interval 5.5 to 40.5
|
10 pg/ml
Interval 7.0 to 24.0
|
PRIMARY outcome
Timeframe: 14+/- 2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 10 Levels at 14+/- 2 Days
|
12 pg/ml
Interval 7.5 to 33.0
|
16 pg/ml
Interval 8.0 to 28.0
|
PRIMARY outcome
Timeframe: 28+/-2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 10 Levels at 28+/-2 Days
|
10 pg/ml
Interval 6.0 to 13.0
|
11 pg/ml
Interval 6.0 to 16.0
|
PRIMARY outcome
Timeframe: 0+2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 17A Levels at 0+2 Days
|
1 pg/ml
Interval 1.0 to 2.0
|
1 pg/ml
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: 14+/- 2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 17A Levels at 14+/- 2 Days
|
1 pg/ml
Interval 1.0 to 1.5
|
1 pg/ml
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: 28+/-2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interleukin 17A Levels at 28+/-2 Days
|
1 pg/ml
Interval 1.0 to 1.0
|
1 pg/ml
Interval 1.0 to 1.7
|
PRIMARY outcome
Timeframe: 0+2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interferon Levels at 0+2 Days
|
6 pg/ml
Interval 5.0 to 9.5
|
6.5 pg/ml
Interval 5.0 to 9.5
|
PRIMARY outcome
Timeframe: 14+/-2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interferon Levels at 14+/-2 Days
|
8 pg/ml
Interval 6.0 to 11.0
|
7.5 pg/ml
Interval 7.0 to 9.0
|
PRIMARY outcome
Timeframe: 28+/-2 daysOutcome measures
| Measure |
Symbiotic
n=25 Participants
symbiotic preparation 1/2 sachet twice daily during 30 days
symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
|
Distilled Water
n=28 Participants
2 x 0.5 cc distilled water will be given during 30 days
distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
|
|---|---|---|
|
Interferon Levels at 28+/-2 Days
|
9 pg/ml
Interval 7.0 to 12.0
|
7 pg/ml
Interval 6.0 to 7.7
|
Adverse Events
Symbiotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Distilled Water
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
Ozge Serce (Investigator, MD)
Zeynep Kamil Maternity and Children's Education Training Hospital
Phone: +905323270375
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place