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

NCT ID: NCT01893814

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30

Brief Summary

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

Conditions

Abdominal Discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotics

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Control

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Control

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 2 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Probi AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Charité Virchow Hospital

Berlin, , Germany

Countries

Germany

Other Identifiers

PAB/029911

Identifier Type: -

Identifier Source: org_study_id