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

NCT04042454 | Completed DMC

• 1 other identifier: EBB18TA19425
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 16

Brief Summary

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

Conditions

Regurgitation, Gastric; Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• To assess the average stool consistency

  8 weeks

• The average stool frequency

  8 weeks

• Incidence of diarrhoea:

  8 weeks, 17 weeks

• IGSQ sum and individual item scores

  2, 4, 8, 17 weeks

• Gut microbiota composition and function

  17 weeks

Study Arms (2)

Test Product

EXPERIMENTAL

Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics

Other: milk based anti-regurgitation infant formula

Control Product

ACTIVE COMPARATOR

Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics

Other: Milk based infant formula

Interventions

milk based anti-regurgitation infant formula OTHER

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.

Test Product

Milk based infant formula OTHER

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.

Control Product

Eligibility Criteria

• Age: 3 Weeks - 9 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Singleton infants with regurgitation who are otherwise healthy
• Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria.
• Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days
• Aged \> 3 weeks (21 days) and \< 9 weeks (63 days) at screening
• Exclusively formula fed for ≥ 7 days before screening
• Written informed consent from the parent(s) and/or legally acceptable representative(s)

You may not qualify if:

• Low birth weight for gestational age and gender
• Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I
• 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
• Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements
• Infants who already started complementary feeding
• Infants with a gastrointestinal infection within 4 weeks prior to screening
• 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
• 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
• Infants known or suspected to have allergy to cow's milk protein
• Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement
• Participation in any other studies involving investigational or marketed products concomitantly or prior to screening
• 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (16)

A.O.U. Ospedali Riuniti di Ancona

Ancona, Italy

Location

Ospedale pediatrico Giovanni XXIII

Bari, Italy

Location

Azienda Ospedaliera Universitaria G. Martino

Messina, Italy

Location

Ospedale dei bambini Buzzi

Milan, Italy

Location

Ospedale F. Del Ponte

Varese, Italy

Location

Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.

Bialystok, Poland

Location

Osrodek badan Klinicznych IN-VIVO sp. z o.o.

Bydgoszcz, Poland

Location

Gabinet Lekarski

Rzeszów, Poland

Location

NZLA Michalkowice Jarosz

Siemianowice Śląskie, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o

Tarnów, Poland

Location

EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o

Żnin, Poland

Location

Communal Nonprofit Enterprise "City Children's Clinical Hospital

Dnipro, Ukraine

Location

Communal Nonprofit Enterprise "City Children's Clinical Hospital

Kharkiv, Ukraine

Location

Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital"

Lviv, Ukraine

Location

Communal Enterprise "Poltava Regional Children's Clinical Hospital of Poltava Regional Council

Poltava, Ukraine

Location

Communal Non-Profit Enterprise of Sumy Regional Council "Regional Children Clinical Hospita

Sumy, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 37204764 RESULT

MeSH Terms

Conditions

Laryngopharyngeal Reflux; Diarrhea

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 2, 2019
• Study Start: December 10, 2019
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: July 13, 2023

Record last verified: 2021-09

Locations

UA (5); IT (5); PL (6)