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

NCT ID: NCT03371615

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-04

Study Completion Date

2019-09-06

Brief Summary

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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

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Conditions

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Regurgitation, Gastric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fermented IF + LBG + Gos Fos

Fermented infant formula with Locust bean gum and Gos Fos

Group Type ACTIVE_COMPARATOR

Anti-regurgitation infant formula

Intervention Type OTHER

Anti regurgitation infant formula

Fermented IF +LBG

Fermented infant formula with Locust bean gum

Group Type PLACEBO_COMPARATOR

Anti-regurgitation infant formula

Intervention Type OTHER

Anti regurgitation infant formula

Interventions

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Anti-regurgitation infant formula

Anti regurgitation infant formula

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Weeks

Maximum Eligible Age

13 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bialystok, , Poland

Site Status

Centrum Medyczne Promed

Krakow, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 34417399 (View on PubMed)

Other Identifiers

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EBB16GL10424

Identifier Type: -

Identifier Source: org_study_id