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

NCT03371615 | Completed DMC

• 1 other identifier: EBB16GL10424
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

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.

Conditions

Regurgitation, Gastric

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fermented IF + LBG + Gos Fos

ACTIVE COMPARATOR

Fermented infant formula with Locust bean gum and Gos Fos

Other: Anti-regurgitation infant formula

Fermented IF +LBG

PLACEBO COMPARATOR

Fermented infant formula with Locust bean gum

Other: Anti-regurgitation infant formula

Interventions

Anti-regurgitation infant formula OTHER

Anti regurgitation infant formula

Fermented IF + LBG + Gos Fos; Fermented IF +LBG

Eligibility Criteria

• Age: 3 Weeks - 13 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (2)

Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K

Bialystok, 15-435, Poland

Location

Centrum Medyczne Promed

Krakow, 31411, Poland

Location

Related 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.

  PMID: 34417399 BACKGROUND

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: December 13, 2017
• Study Start: November 4, 2017
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: December 30, 2021

Record last verified: 2019-11

Locations

PL (2)