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

NCT01893814 | Terminated Phase 2

• 1 other identifier: PAB/029911
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Discomfort

Outcome Measures

Primary Outcomes (1)

• Reduction of abdominal discomfort as assessed by comparison of crying time

  28 days

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Dietary Supplement: Probiotics

Control

PLACEBO COMPARATOR

Dietary Supplement: Control

Interventions

Probiotics DIETARY_SUPPLEMENT

Probiotics

Control DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 2 Weeks - 12 Weeks
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Probi AB: lead

Study Sites (1)

Charité Virchow Hospital

Berlin, 13353, Germany

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

DE (1)