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

P

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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