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OpenTrials
Completed

NCT Number: NCT04915937

Formula Tolerance of Term Infants

To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants

Completed

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Key information

Age range

7 day–65 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedPharmics, LLC, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is judged to be in good health as determined from participant's medical history by parent report
  • Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
  • Participant's birth weight was >= 2490 g (~5 lbs. 8 oz.)
  • Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
  • Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
  • Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
  • Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local privacy regulation authorization prior to any participation in the study

Exclusion criteria

  • An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse.
  • Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
  • Participant participates in another study that has not been approved as a concomitant study
  • Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
  • Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
  • Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
  • Participant has been treated with antibiotics within 7 days prior to enrollment

Treatment and study plan

Study Infant Formula

Other

RTF milk-based infant formula with oligosaccharides

Primary outcomes

  1. Fussiness

    Time frame: Baseline to Study Day (SDAY) 2

    Absolute and % change in fussiness severity reported from Daily Tolerance Diary

Secondary outcomes

  1. Gastrointestinal Tolerance

    Time frame: Baseline to SDAY 28

    Parent Completed Diary

  2. Stool

    Time frame: Baseline to SDAY 28

    Parent Completed Diary

Other outcomes

  1. Formula Intake

    Time frame: SDAY 1 to SDAY 28

    Parent Completed Diary

  2. Weight

    Time frame: SDAY 1 to SDAY 28

    Weight gains, percentiles, and z-scores

  3. Length

    Time frame: SDAY 1 to SDAY 28

    Length gains, percentiles, and z-scores

  4. Infant Feeding and Stool Patterns Questionnaire

    Time frame: SDAY 1 and SDAY 28

    Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from frequent to less frequent

  5. Formula Satisfaction Questionnaire

    Time frame: SDAY 1 and SDAY 28

    Parent completed questionnaire; 13 questions of up to 5 categories scaled from positive to negative

  6. Parental perspectives

    Time frame: SDAY 1 and SDAY 28

    Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive

  7. Health Resource Utilization

    Time frame: SDAY 7 and SDAY 28

    Number of Visits

  8. Adverse Events

    Time frame: SDAY 1 to SDAY 28

    Standard adverse event reporting

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Tolerance of Term Infants Fed Formula With Oligosaccharides

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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