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Role of ProTectis on Infant Colic and Its Effect on Infant Crying Time and Maternal Mental Health (PRIC-SMM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Ferozsons Laboratories Ltd..
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Dr. Parveen Akhtar, Ferozsons Laboratories Ltd. Identifier:
First received: March 13, 2014
Last updated: March 19, 2014
Last verified: March 2014

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

Condition Intervention
Infantile Colic
Infant Sleeping Habits
Maternal Mental Health.
Other: ProTectis drops (five drops per day) for 21 days
Other: Placebo drops (five drops per day) for 21 days

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: L.Reuteri ProTectis DSM 17938 to Relieve Infant Colic and Its Effects on Infant Sleep Pattern & Maternal Mental Health. PRIC-SMM Trial

Resource links provided by NLM:

Further study details as provided by Ferozsons Laboratories Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in the duration of crying (minutes per day). [ Time Frame: Base line, day 7, day 14, day 21 & day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A reduction in the daily average crying time, to <3 h/d. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Change in Infant sleep duration in (minutes/day) [ Time Frame: Baseline, day 7, day 14, day 21& day 28 ] [ Designated as safety issue: No ]
  • Change in Maternal mental health scores. [ Time Frame: Baseline, day 21 & day 28 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Persistence of infantile colic after the intervention. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change in the Parental perceptions of colic severity [ Time Frame: Baseline, day 7, day 14, day 21 & day 28 ] [ Designated as safety issue: No ]
  • Change in the Parental/ family quality of life [ Time Frame: Baseline, day 21 & day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: ProTectis drops
Arm A.
Other: ProTectis drops (five drops per day) for 21 days
Placebo Comparator: Placebo drops
Arm B
Other: Placebo drops (five drops per day) for 21 days

  Show Detailed Description


Ages Eligible for Study:   up to 3 Months   (Child)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02094092

Fauji Foundation Hospital
Rawalpindi, Punjab, Pakistan
Sponsors and Collaborators
Ferozsons Laboratories Ltd.
Principal Investigator: Parveen Akhter, Dr. Fauji Foundation Hospital, Rawalpindi
  More Information

Responsible Party: Dr. Parveen Akhtar, Head of Pediatric Department, Fauji Foundation Hospital, Ferozsons Laboratories Ltd. Identifier: NCT02094092     History of Changes
Other Study ID Numbers: FZSPBT001 
Study First Received: March 13, 2014
Last Updated: March 19, 2014
Health Authority: Pakistan: Ministry of Health

Keywords provided by Ferozsons Laboratories Ltd.:
L.reuteri ProTectis DSM 17938
Infantile colic
Maternal mental health.
Infant crying/fussing
Edinburgh Postnatal Depression Scale (EPDS)

Additional relevant MeSH terms:
Infant, Newborn, Diseases processed this record on December 08, 2016