Clinical trial NCT04042454: To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
Official title: A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regurgitation, Gastric
Diarrhea
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 103
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Average stool consistency
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess the average stool consistency
timeFrame: 8 weeks
measure: The average stool frequency
timeFrame: 8 weeks
measure: Incidence of diarrhoea:
timeFrame: 8 weeks, 17 weeks
measure: IGSQ sum and individual item scores
timeFrame: 2, 4, 8, 17 weeks
measure: Gut microbiota composition and function
timeFrame: 17 weeks
measure: Regurgitation
timeFrame: 2,4,8,17 weeks
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti di Ancona
city: Bari
country: Italy
facility: Ospedale pediatrico Giovanni XXIII
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria G. Martino
city: Milano
country: Italy
facility: Ospedale dei bambini Buzzi
city: Varese
country: Italy
facility: Ospedale F. Del Ponte
city: Białystok
country: Poland
facility: Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
city: Bydgoszcz
country: Poland
facility: Osrodek badan Klinicznych IN-VIVO sp. z o.o.
city: Rzeszów
country: Poland
facility: Gabinet Lekarski
city: Siemianowice Śląskie
country: Poland
facility: NZLA Michalkowice Jarosz
city: Tarnów
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o
city: Żnin
country: Poland
facility: EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o
city: Dnipro
country: Ukraine
facility: Communal Nonprofit Enterprise "City Children's Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Communal Nonprofit Enterprise "City Children's Clinical Hospital
city: Lviv
country: Ukraine
facility: Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital"
city: Poltava
country: Ukraine
facility: Communal Enterprise "Poltava Regional Children's Clinical Hospital of Poltava Regional Council
city: Sumy
country: Ukraine
facility: Communal Non-Profit Enterprise of Sumy Regional Council "Regional Children Clinical Hospita
Study officials:
References:
citation: 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.