PRIC-SMM
L.Reuteri ProTectis DSM 17938 to Relieve Infant Colic and Its Effects on Infant Sleep Pattern & Maternal Mental Health. PRIC-SMM Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will work on hypothetical assumption that compared to the arm supplemented with placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing time per 24 hours at one month post randomization. And that the L reuteri (intervention) group at 7, 14, 21, days and 1 week after the therapy cessation will have:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 13, 2014
Actual (reported)March 21, 2014
Actual (reported)May 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The treatment success (defined as the percentage of children achieving a reduction in the daily average crying time 50% during the study)
Day 28
Change in the duration of crying (minutes per day).
Base line, day 7, day 14, day 21 & day 28
A reduction in the daily average crying time, to <3 h/d.
Day 21
Arm A.
Arm B
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Fauji Foundation Hospital
Rawalpindi, Punjab Province, Pakistan
Parveen Akhter, Dr.
Fauji Foundation Hospital
First Submitted
March 13, 2014
First Posted
March 21, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Change in Infant sleep duration in (minutes/day)
Baseline, day 7, day 14, day 21& day 28
Change in Maternal mental health scores.
Baseline, day 21 & day 28
Persistence of infantile colic after the intervention.
Day 28
Change in the Parental perceptions of colic severity
Baseline, day 7, day 14, day 21 & day 28
Change in the Parental/ family quality of life
Baseline, day 21 & day 28
Contact the study team to confirm eligibility.
March 2016
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 21, 2014
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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