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OpenTrials
Completed

NCT Number: NCT02021058

Study in Unsettled Infants Experiencing Feeding Intolerance

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

Completed

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Key information

Conditions

Feeding Disorder Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

30 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full term infants, singleton, healthy at birth
  • Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
  • Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
  • 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

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

Treatment and study plan

Experimental formula

Other

Experimental formula

Standard control formula

Other

Standard Infant formula

Primary outcomes

  1. Changes from baseline to 14 days in fuss-cry behavior

    Time frame: from baseline to 14 days

    fuss-cry behavior per 24 hours

Secondary outcomes

  1. Change from baseline to 14 days in GI symptoms

    Time frame: from baseline to 14 days

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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