NCT02094092

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

March 13, 2014

Last Update Submit

March 19, 2014

Conditions

Infantile ColicInfant Sleeping HabitsMaternal Mental Health.

Keywords

L.reuteri ProTectis DSM 17938Infantile colicMaternal mental health.Infant crying/fussingEdinburgh Postnatal Depression Scale (EPDS)

Outcome Measures

Primary Outcomes (2)

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

    Day 28

  • Change in the duration of crying (minutes per day).

    Base line, day 7, day 14, day 21 & day 28

Secondary Outcomes (3)

  • 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

Other Outcomes (3)

  • Persistence of infantile colic after the intervention.

    Day 28

  • Change in the Parental perceptions of colic severity

    Baseline, day 7, day 14, day 21 & day 28

  • Change in the Parental/ family quality of life

    Baseline, day 21 & day 28

Study Arms (2)

ProTectis drops

PLACEBO COMPARATOR

Arm A.

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

Placebo drops

PLACEBO COMPARATOR

Arm B

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

Interventions

ProTectis drops (five drops per day) for 21 daysOTHER
ProTectis drops
Placebo drops (five drops per day) for 21 daysOTHER
Placebo drops

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Colic

Interventions

WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Parveen Akhter, Dr.

    Fauji Foundation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Department, Fauji Foundation Hospital

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 21, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

PA(1)