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

Regurgitation, Gastric Clinical Trial

— Leopard  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371615
• Other study ID #: EBB16GL10424
• Status: Completed
• Phase: N/A
• Start date: November 4, 2017
• Est. completion date: September 6, 2019

Study information

• Verified date: November 2019
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 13 Weeks

Eligibility

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.

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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.

Related Conditions & MeSH terms

• Laryngopharyngeal Reflux
• Regurgitation, Gastric

Intervention

Other:
• Anti-regurgitation infant formula
Anti regurgitation infant formula

Locations

Country	Name	City	State
Poland	Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K	Bialystok
Poland	Centrum Medyczne Promed	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Bellaiche M, Ludwig T, Arciszewska M, Bongers A, Gomes C, Swiat A, Dakhlia F, Piollet A, Oozeer R, Vandenplas Y. Safety and Tolerance of a Novel Anti-Regurgitation Formula: A Double-Blind, Randomized, Controlled Trial. J Pediatr Gastroenterol Nutr. 2021 Nov 1;73(5):579-585. doi: 10.1097/MPG.0000000000003289. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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