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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893814
Recruitment Status : Terminated (Poor recruitment)
First Posted : July 9, 2013
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Probi AB

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

Condition or disease Intervention/treatment Phase
Abdominal Discomfort Dietary Supplement: Probiotics Dietary Supplement: Control Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2013
Actual Primary Completion Date : January 2014

Arm Intervention/treatment
Active Comparator: Probiotics Dietary Supplement: Probiotics
Placebo Comparator: Control Dietary Supplement: Control



Primary Outcome Measures :
  1. Reduction of abdominal discomfort as assessed by comparison of crying time [ Time Frame: 28 days ]


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Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893814


Locations
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Germany
Charité Virchow Hospital
Berlin, Germany, 13353
Sponsors and Collaborators
Probi AB

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Responsible Party: Probi AB
ClinicalTrials.gov Identifier: NCT01893814     History of Changes
Other Study ID Numbers: PAB/029911
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016