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

Probi AB

Status and phase: Terminated; Phase 2

Conditions: Abdominal Discomfort

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01893814

PAB/029911

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 2 to 12 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Treatment:

Dietary Supplement: Probiotics

Control

Placebo Comparator group

Treatment:

Dietary Supplement: Control