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

Abdominal Discomfort Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01893814
• Other study ID #: PAB/029911
• Status: Terminated
• Phase: Phase 2
• First received: July 2, 2013
• Last updated: September 21, 2016
• Start date: April 2013

Study information

• Verified date: September 2016
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. primary completion date: January 2014
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Discomfort

Intervention

Dietary Supplement:
• Probiotics

• Control

Locations

Country	Name	City	State
Germany	Charité Virchow Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of abdominal discomfort as assessed by comparison of crying time		28 days	No