Abdominal Discomfort
Conditions
Brief summary
To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.
Interventions
DIETARY_SUPPLEMENTProbiotics
DIETARY_SUPPLEMENTControl
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 12 Weeks
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of abdominal discomfort as assessed by comparison of crying time | 28 days |
Countries
Germany
Outcome results
None listed