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Infantile Colic | Role of ProTectis on Infant Colic and Its Effect on Infant Crying Time and Maternal Mental Health

Infantile Colic research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infantile Colic

Infant Sleeping Habits

Maternal Mental Health.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:ProTectis drops (five drops per day) for 21 days

Other:Placebo drops (five drops per day) for 21 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ProTectis dropsArm A.

Placebo dropsArm B

Study Status

Unknown status

Start Date: May 2014

Completed Date: March 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The treatment success (defined as the percentage of children achieving a reduction in the daily average crying time 50% during the study)

Secondary Outcome: A reduction in the daily average crying time, to <3 h/d.

Study sponsors, principal investigator, and references

Principal Investigator: Parveen Akhter, Dr.

Lead Sponsor: Ferozsons Laboratories Ltd.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02094092

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