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

NCT ID: NCT04042454

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2023-05-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Test Product

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

Group Type: EXPERIMENTAL

milk based anti-regurgitation infant formula

Intervention Type: 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.

Control Product

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

Group Type: ACTIVE_COMPARATOR

Milk based infant formula

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Weeks
• Maximum Eligible Age: 9 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Milan, , Italy

Ospedale F. Del Ponte

Varese, , Italy

Poliklinika Ginekologiczno-Położnicza 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 Śląskie, , Poland

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

Tarnów, , Poland

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

Żnin, , Poland

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, , Ukraine

Countries

Italy; Poland; Ukraine

References

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.

Reference Type: RESULT

PMID: 37204764 (View on PubMed)

Other Identifiers

EBB18TA19425

Identifier Type: -

Identifier Source: org_study_id