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

Not Applicable

Completed

• Conditions: Regurgitation, Gastric
• Interventions: Other: Anti-regurgitation infant formula

• Registration Number: NCT03371615
• Lead Sponsor: Nutricia Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-24
• Study Start: 2017-11-04
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-13
• Primary Completion: 2019-09-06
• Study Completion: 2019-09-06
• Status Verified: 2019-11
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fermented IF + LBG + Gos Fos	Anti-regurgitation infant formula	Fermented infant formula with Locust bean gum and Gos Fos
Fermented IF +LBG	Anti-regurgitation infant formula	Fermented infant formula with Locust bean gum

Primary Outcome Measures

Name	Time	Method
GI tolerance	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

Trial Locations

Locations (2)

Centrum Medyczne Promed; 🇵🇱 Kraków, Poland

Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K; 🇵🇱 Białystok, Poland