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

NCT02094092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-21

No results posted yet for this study

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

Conditions

  • Infantile Colic
  • Infant Sleeping Habits
  • Maternal Mental Health.

Interventions

OTHER

ProTectis drops (five drops per day) for 21 days

OTHER

Placebo drops (five drops per day) for 21 days

Sponsors & Collaborators

  • Ferozsons Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Parveen Akhter, Dr. · Fauji Foundation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02094092 on ClinicalTrials.gov