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: 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
- 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
- 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
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.
- 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
- Lead Sponsor
- Nutricia Research
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Jan van der Mooren, MD, phD, +31 30 2095573, email@example.com
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