Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying

NCT01956682 | Completed Phase 4 DMC

• 1 other identifier: University of Bari
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.

Conditions

Regurgitation, Gastric

Outcome Measures

Primary Outcomes (1)

• Regurgitation

  The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.

  four weeks of treatment

Secondary Outcomes (7)

• Growth

  Four weeks of treatment

• Regurgitation score

  Four weeks treatment

• Gastric empty rate

  Four week treatment

• Digestive tolerance

  Four weeks treatment

• Stool frequency

  Four weeks treatment

Study Arms (2)

Infant formula

ACTIVE COMPARATOR

HA formula + starch + L. reuteri

Dietary Supplement: HA formula + starch + L. reuteri

Standard Formula

PLACEBO COMPARATOR

Standard Infant Formula

Interventions

HA formula + starch + L. reuteri DIETARY_SUPPLEMENT

Infant formula

Eligibility Criteria

• Age: 5 Days - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
• Age of infant between 5 days and 5 months
• NGA
• Infant exclusively formula-fed at enrollment
• Presenting regurgitation/spitting-up according to the parents' perception
• Vandenplas score of at least 2 and maximum 5
• Having obtained the subject's legal representative's written informed consent

You may not qualify if:

• Previous antireflux treatment
• Previous consumption of AR infant formula or external thickener
• Previous consumption of a formula with L. reuteri
• Cow's milk allergy symptoms according to medical decision
• Congenital illness or malformation that may affect growth
• Significant pre-natal and/or post-natal disease
• Newborn whose parents / caregivers cannot be expected to comply with study procedures
• Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Ospedale Pediatrico Giovanni XXIII

Bari, BA, 70100, Italy

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Interventions

Starch

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Flavia Indrio, MD

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

IT (1)