L.Reuteri ProTectis DSM 17938 to Relieve Infant Colic and Its Effects on Infant Sleep Pattern & Maternal Mental Health. PRIC-SMM Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The treatment success (defined as the percentage of children achieving a reduction in the daily average crying time 50% during the study)
Study Overview
Brief Summary
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:
- Lower crying/fussing time per 24 hours.
- Relief from colic pain
- Longer sleep duration,
- Higher scores on a standardized measure of maternal mental health
Detailed Description
The present study is aimed to test the hypothesis that "modulating" the gut micro flora of colicky infants through the oral administration of Probiotic- ProTectis would not only decrease crying time related to infantile colic but will also improve sleeping habits of infant and consequently decrease/eradicate maternal mental stress.
- This is a prospective, single center, Randomized, Double Blind, and Placebo Controlled Study. The study will be conducted according to GCP guidelines and in accordance with declaration of Helsinki. The protocol and informed consent will be approved by ethical committee of study center prior to initiation. Enrollment of infants in study will take place only after the procurement of written informed consent from parents.
Minimum 60 patients will be recruited and assessed over 1 week after treatment to characterize the pattern of product related adverse events (as per ICH- E1Guidelines criteria required for safety assessment for drugs intended for short term treatment). Personal and clinical data will be collected from CRF given to Investigator for a period of 3 weeks of treatment after the date of randomization and treatment initiation. Follow-up and causality assessment of medically significant events will also be undertaken.Study comprises of 5 total visits including Visit 1 that will be the recruitment, screening and treatment initiation visit. Clinical evaluation for patient eligibility will be assessed at this visit before final enrolment. Patient will be asked to come at day7 (visit 2), day14 (visit3), day21 (visit4), and a visit one week after visit 4(follow up visit 5) to monitor any change in treatment parameter and also to assess any AaDR. Any labs if required will be done at the discretion of investigator. Patient will be instructed to promptly report any unexplained side effects.
- Study Analysis Upon completion of study duration, data will be analyzed to find out its effect on efficacy points set for concluding study results.
For statistical analysis, Data will be entered and analyzed using SPSS version19. Some esoteric statistical test will be applied like percentages will be calculated for checking efficacy and for comparison we will apply paired t-test, also for graphical representation, we will make bar charts and pie charts. 2. Study Duration:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- — to 3 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All infants (Full term with gestational age > 37 weeks and < 41 weeks) aged <3 months with infantile colic (defined as crying episodes lasting 3 or more hours/day and occurring at least 3 days/week within 7 days prior to enrollment)
- •Infants who were exclusively or predominantly (>50%) breastfed/fed on Fresh Milk i.e.; cow milk/buffalo/tetra pack.
Exclusion Criteria
- •Acute or chronic illness
- •Gastrointestinal disorders
- •Use of any antibiotics and/or probiotic pharmaceutical products within 7 days prior to the study.
- •Infants taking Probiotic containing infant formula milks.
Arms & Interventions
ProTectis drops
Arm A.
Intervention: ProTectis drops (five drops per day) for 21 days (Other)
Placebo drops
Arm B
Intervention: Placebo drops (five drops per day) for 21 days (Other)
Outcomes
Primary Outcomes
The treatment success (defined as the percentage of children achieving a reduction in the daily average crying time 50% during the study)
Time Frame: Day 28
Change in the duration of crying (minutes per day).
Time Frame: Base line, day 7, day 14, day 21 & day 28
Secondary Outcomes
- A reduction in the daily average crying time, to <3 h/d.(Day 21)
- 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)
Investigators
Dr. Parveen Akhtar
Head of Pediatric Department, Fauji Foundation Hospital
Ferozsons Laboratories Ltd.