Status:
TERMINATED
Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort
Lead Sponsor:
Probi AB
Conditions:
Abdominal Discomfort
Eligibility:
All Genders
2-12 years
Phase:
PHASE2
Brief Summary
To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01893814
Start Date
April 1 2013
Last Update
September 22 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité Virchow Hospital
Berlin, Germany, 13353