Clinical trial NCT02021058: Study in Unsettled Infants Experiencing Feeding Intolerance
Official title: Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Disorder
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 259
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance

Detailed description: The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.

Eligibility criteria: Inclusion Criteria:

1. Full term infants, singleton, healthy at birth
2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
4. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.

Exclusion Criteria:

1. Infants who are consuming any amount of supplemental human milk
2. Infants who are consuming weaning foods or beverages other than infant formula
3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance
5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment

Primary outcomes:
measure: Changes from baseline to 14 days in fuss-cry behavior
timeFrame: from baseline to 14 days
Secondary outcomes:
measure: Change from baseline to 14 days in GI symptoms
timeFrame: from baseline to 14 days
Other outcomes:
Locations:
city: Shatin, New Territories
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
city: Hsiang, Taoyan Hsien
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: New Taipei City
country: Taiwan
facility: Mackay Memorial Hospital - Tamsui
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital - Taipei
city: Pratumwan, Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Pediatric Department, Faculty of Medicine, Chulalongkorn University
name: Associate Professor Boosba Vivatvakin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vivatvakin B, Estorninos E, Lien R, Lee HC, Hon KLE, Lebumfacil J, Cercamondi CI, Volger S. Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial. Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.