To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation (Solar)

Nutricia

Status: Completed

Conditions: Diarrhea; Regurgitation, Gastric

Treatments: Other: milk based anti-regurgitation infant formula; Other: Milk based infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT04042454

EBB18TA19425

Details and patient eligibility

About

A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)

Enrollment: 103 patients

Sex: All

Ages: 3 to 9 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Singleton infants with regurgitation who are otherwise healthy
2. Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria.
3. Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days
4. Aged > 3 weeks (21 days) and < 9 weeks (63 days) at screening
5. Exclusively formula fed for ≥ 7 days before screening
6. Written informed consent from the parent(s) and/or legally acceptable representative(s)

Exclusion criteria

1. Low birth weight for gestational age and gender
2. Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I
3. Infants who received any of the following medication within 4 weeks prior to screening: systemic antibiotics, prokinetics and/or proton pump inhibitors and/or (other) medication to treat regurgitation
4. Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements
5. Infants who already started complementary feeding
6. Infants with a gastrointestinal infection within 4 weeks prior to screening
7. Infants with a congenital condition, previous or current illness, and/or medication use that could interfere with the main study outcomes according to the investigator
8. Infants known or suspected to have: allergy for fish, soy protein, soy oil or corn; lactose intolerance; galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients and/or requiring a fibre-free diet
9. Infants known or suspected to have allergy to cow's milk protein
10. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement
11. Participation in any other studies involving investigational or marketed products concomitantly or prior to screening
12. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 2 patient groups

Test Product

Experimental group

Description:

Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics

Treatment:

Other: milk based anti-regurgitation infant formula

Control Product

Active Comparator group

Description:

Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics

Treatment:

Other: Milk based infant formula