Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula

Overview

A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.

Full Title of Study: “A Randomised, Controlled, Double Blind Trial to Evaluate the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula Containing Prebiotics and Locust Bean Gum in Infants With Regurgitation.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 1, 2020

Interventions

  • Other: Anti-regurgitation infant formula
    • Anti regurgitation infant formula

Arms, Groups and Cohorts

  • Active Comparator: Fermented IF + LBG + Gos Fos
    • Fermented infant formula with Locust bean gum and Gos Fos
  • Placebo Comparator: Fermented IF +LBG
    • Fermented infant formula with Locust bean gum

Clinical Trial Outcome Measures

Primary Measures

  • GI tolerance
    • Time Frame: 4 weeks
    • To assess the gastrointestinal (GI) tolerance of the investigational product compared to the control product based on Infant Gastrointestinal Symptom Questionnaire(IGSQ) symptoms score containg 13 questions on a 7 point scale

Participating in This Clinical Trial

Inclusion Criteria

1. Singleton healthy term infant aged 3 – 13 weeks;

2. Gestational age at birth 37- 42 weeks;

3. Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts;

4. Infants with regurgitation that are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation.

5. Fully formula fed for at least 7 days before screening/randomisation;

6. Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.

Exclusion Criteria

  • 1. History of retching, hematemesis, aspiration, apnoea, failure to thrive, feeding or swallowing difficulties or abnormal posturing; 2. Gastrointestinal infection within 4 weeks prior to randomisation; 3. Congenital condition and/or previous or current illness and (or) medication use that could interfere with the main study outcomes according to the investigator; 4. Known cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients (especially scGOS); 5. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement; 6. Received any of the following products/medication prior to randomisation: systemic antibiotics, prokinetics, proton pump inhibitors, complementary feeding/weaning within 4 weeks prior to randomisation; 7. Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements; 8. Current participation in another clinical intervention study.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 13 Weeks

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nutricia Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jan van der Mooren, MD, phD, +31 30 2095573, jan.vandermooren@danone.com

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