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

Nutricia

Status: Completed

Conditions: Regurgitation, Gastric

Treatments: Other: Anti-regurgitation infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT03371615

EBB16GL10424

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 3 to 13 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 2 patient groups, including a placebo group

Fermented IF + LBG + Gos Fos

Active Comparator group

Description:

Fermented infant formula with Locust bean gum and Gos Fos

Treatment:

Other: Anti-regurgitation infant formula

Fermented IF +LBG

Placebo Comparator group

Description:

Fermented infant formula with Locust bean gum

Treatment:

Other: Anti-regurgitation infant formula