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

Phase 2

Terminated

• Conditions: Abdominal Discomfort
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Control

• Registration Number: NCT01893814
• Lead Sponsor: Probi AB

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2014-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Reduction of abdominal discomfort as assessed by comparison of crying time	28 days

Trial Locations

Locations (1)

Charité Virchow Hospital; 🇩🇪 Berlin, Germany