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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Regurgitation, Gastric

Intervention / Treatment
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* Other: Anti-regurgitation infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton healthy term infant aged 3 - 13 weeks; Gestational age at birth 37- 42 weeks; Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts; 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. Fully formula fed for at least 7 days before screening/randomisation; 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.

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 13 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fermented IF + LBG + Gos Fos<br>Fermented infant formula with Locust bean gum and Gos Fos | Other: Anti-regurgitation infant formula<br>* Anti regurgitation infant formula<br>|
| Placebo Comparator: Fermented IF +LBG<br>Fermented infant formula with Locust bean gum | Other: Anti-regurgitation infant formula<br>* Anti regurgitation infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI tolerance | 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 | 4 weeks |