An interventional study of L. reuteri DSM 17938 in drops and Placebo in Infantile Colic, sponsored by Innovacion y Desarrollo de Estrategias en Salud. Status unknown at 1 site in Mexico. Open to participants aged 1 Week to 9 Weeks. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by Innovacion y Desarrollo de Estrategias en Salud · Not applicable, Interventional, and Treatment
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21
154 studies on the registry are indexed under Colic; 20 are open to participants now.
This study's planned enrollment of 244 is above the median of 80 across 128 interventional studies indexed under Colic.
Browse Colic studies →Innovacion y Desarrollo de Estrategias en Salud is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties
Dietary Supplement: L. reuteri DSM 17938 in drops
The placebo consists of an identical formulation except that the L. reuteri is not present
Other: Placebo
L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties
Dietary Supplement: L. reuteri DSM 17938 in drops
The placebo consists of an identical formulation except that the L. reuteri is not present
Other: Placebo
L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle
The placebo consists of an identical formulation except that the L. reuteri is not present
Crying time
Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary.
Time frame: 21 days
Preliminary crying time
Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group
Time frame: Day 7 and 14
Crying and fussing
Average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group
Time frame: 7,14 and 21 days
Total responders
Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study
Time frame: 7,14 and 21 days
Impact on Quality of Life
Impact on Quality of Life measured by PedsQL-2.0-Family Impact Module AU2.0 spa-MX. Changes from baseline to days 7, 14 and 21
Time frame: 7, 14 and 21 days
Maternal depression
Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 7, 14 and 21 days
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Nov 2019, 22 months after the start.
Of 37 non-industry interventional studies with no phase under Colic, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 22 months is above that.
Counting every sponsor, half of 48 studies reached it within 18 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Innovacion y Desarrollo de Estrategias en Salud