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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Ferozsons Laboratories Ltd.
Sponsor:
Information provided by (Responsible Party):
Dr. Parveen Akhtar, Ferozsons Laboratories Ltd.
ClinicalTrials.gov Identifier:
NCT02094092
First received: March 13, 2014
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02094092

Locations
Pakistan
Fauji Foundation Hospital Not yet recruiting
Rawalpindi, Punjab, Pakistan
Contact: Parveen Akhtar, Dr    +92-515788104    pervtariq@hotmail.com   
Principal Investigator: Perveen Akhtar, Dr.         
Sponsors and Collaborators
Ferozsons Laboratories Ltd.
Investigators
Principal Investigator: Parveen Akhter, Dr. Fauji Foundation Hospital Rawalpindi
  More Information

No publications provided

Responsible Party: Dr. Parveen Akhtar, Head of Pediatric Department, Fauji Foundation Hospital, Ferozsons Laboratories Ltd.
ClinicalTrials.gov 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:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on July 23, 2014