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

Diarrhea Clinical Trial

— Solar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042454
• Other study ID #: EBB18TA19425
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: May 23, 2023

Study information

• Verified date: September 2021
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Weeks to 9 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Laryngopharyngeal Reflux
• Regurgitation, Gastric

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	A.O.U. Ospedali Riuniti di Ancona	Ancona
Italy	Ospedale pediatrico Giovanni XXIII	Bari
Italy	Azienda Ospedaliera Universitaria G. Martino	Messina
Italy	Ospedale dei bambini Buzzi	Milano
Italy	Ospedale F. Del Ponte	Varese
Poland	Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp. k.	Bialystok
Poland	Osrodek badan Klinicznych IN-VIVO sp. z o.o.	Bydgoszcz
Poland	Gabinet Lekarski	Rzeszów
Poland	NZLA Michalkowice Jarosz	Siemianowice Slaskie
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o	Tarnów
Poland	EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o	Znin
Ukraine	Communal Nonprofit Enterprise "City Children's Clinical Hospital	Dnipro
Ukraine	Communal Nonprofit Enterprise "City Children's Clinical Hospital	Kharkiv
Ukraine	Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital"	Lviv
Ukraine	Communal Enterprise "Poltava Regional Children's Clinical Hospital of Poltava Regional Council	Poltava
Ukraine	Communal Non-Profit Enterprise of Sumy Regional Council "Regional Children Clinical Hospita	Sumy

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Countries where clinical trial is conducted

Italy,  Poland,  Ukraine, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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