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

A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation

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

Study Overview

• Status: Completed
• Conditions: Diarrhea; Regurgitation, Gastric
• Intervention / Treatment: Other: milk based anti-regurgitation infant formula; Other: Milk based infant formula

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • A.O.U. Ospedali Riuniti di Ancona
  • Bari, Italy
    • Ospedale Pediatrico Giovanni XXIII
  • Messina, Italy
    • Azienda Ospedaliera Universitaria G. Martino
  • Milano, Italy
    • Ospedale dei bambini Buzzi
  • Varese, Italy
    • Ospedale F. Del Ponte
• Poland
  • Białystok, Poland
    • Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
  • Bydgoszcz, Poland
    • Osrodek Badan Klinicznych In-Vivo Sp. z o.o.
  • Rzeszów, Poland
    • Gabinet Lekarski
  • Siemianowice Śląskie, Poland
    • NZLA Michalkowice Jarosz
  • Tarnów, Poland
    • Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o
  • Żnin, Poland
    • EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o
• Ukraine
  • Dnipro, Ukraine
    • Communal Nonprofit Enterprise "City Children's Clinical Hospital
  • Kharkiv, Ukraine
    • Communal Nonprofit Enterprise "City Children's Clinical Hospital
  • Lviv, Ukraine
    • Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital"
  • Poltava, Ukraine
    • Communal Enterprise "Poltava Regional Children's Clinical Hospital of Poltava Regional Council
  • Sumy, Ukraine
    • Communal Non-Profit Enterprise of Sumy Regional Council "Regional Children Clinical Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product; Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics	Other: milk based anti-regurgitation infant formula; Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
Active Comparator: Control Product; Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics	Other: Milk based infant formula; Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average stool consistency	The average stool consistency (based on the 4-point Brussels Infant and Toddler Stool Scale [BITSS]) of the 8th week of intervention, adjusted for the baseline stool consistency score. Catagories are hard stools, formed stools, loose stools and watery stools. https://bitss-stoolscale.com/ (assessed 31-Jan-19) can be used as a further reference.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the average stool consistency	The average stool consistency based on the BITSS, adjusted for baseline, for every week until the 8th week of intervention and for the week prior to the age of 17 weeks	8 weeks
The average stool frequency	The average stool frequency, adjusted for baseline, for every week until and including the 8th week of intervention and for the week prior to the age of 17 weeks	8 weeks
Incidence of diarrhoea:	based on the WHO criteria and derived from the BITSS, for every week (until and including week 8 of intervention, and at the age of 17 weeks); based on investigator's diagnosis of diarrhoea (throughout the entire study)	8 weeks, 17 weeks
IGSQ sum and individual item scores	IGSQ sum and individual item scores, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks	2, 4, 8, 17 weeks
Gut microbiota composition and function	Gut microbiota composition and function (acetate, lactate, pH, calprotectin, ammonium and sIgA) at baseline and at the age of 17 weeks	17 weeks
Regurgitation	Regurgitation: number of regurgitation episodes per day and the regurgitation volume score, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks (based on 3-day diaries)	2,4,8,17 weeks

Collaborators and Investigators

• Sponsor: Nutricia Research

Publications and helpful links

General Publications

• ESPGHAN 55th Annual Meeting Abstracts. J Pediatr Gastroenterol Nutr. 2023 Jun 1;76(S1 Suppl 1):1-1407. doi: 10.1097/MPG.0000000000003823. Epub 2023 May 19. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Diarrhea; Laryngopharyngeal Reflux
• Other Study ID Numbers: EBB18TA19425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No