Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort

To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.

Study Overview

• Status: Terminated
• Conditions: Abdominal Discomfort
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Probiotics

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité Virchow Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 2 months (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female singleton
• ≥ 2 weeks and ≤ 12 weeks of age
• Exclusively breastfed at screening
• Abdominal discomfort (infant colic) in the week prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
• Episodes of fussy crying that lasted at least 3 hours a day for at least 3 days in the 7 days prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
• Voluntary, written informed consent of the parent(s) and/or guardian(s) to participate in the study
• Born at full term (37-42 after last menstruation period)
• Birth weight: 2500 - 4500 g
• Weight-for-age ≥ 3th and ≤ 97th percentile according to WHO growth tables / charts
• Apparently healthy at birth (Apgar ≥ 8) and at screening visit
• No major complications during pregnancy or at birth
• Mother 19-45 years of age at childbirth
• Ability of parent(s) and/or guardian(s) to attend visits, interviews and willingness to fill out questionnaires

Exclusion Criteria:

• Intolerance to investigational product/its ingredients
• Severe medical condition or illness, congenital abnormality
• Gastrointestinal disorders (e.g. reflux esophagitis)
• Intake of probiotics and/or antibiotics in the week preceding recruitment and during the study
• Formula feeding at screening/randomisation
• Allergy or atopic disease (family history)
• Participation in another study
• Mother's health condition that may interfere with her ability to take care of her infant
• Mother affected by hepatitis B, HIV or Guillain-Barré Syndrome
• Use of antibiotics by the mother in the week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Dietary supplement: Control
Active Comparator: Probiotics	Dietary supplement: Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of abdominal discomfort as assessed by comparison of crying time	28 days

Collaborators and Investigators

• Sponsor: Probi AB

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 9, 2013

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PAB/029911