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Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas

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ClinicalTrials.gov Identifier: NCT01861600
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : May 23, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.

Condition or disease Intervention/treatment Phase
Stool Composition Other: S-26 Gold Other: S-26 Gold EF1 Other: S-26 Gold EF2 Other: S-26 Gold EF3 Other: Human Milk Phase 3

Detailed Description:
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition and characteristics and to investigate the effect of both high 2-palmitic vegetable oil and oligofructose in infant formula on stool softness and bacteria. Because some studies demonstrate the benefit of high concentrations of a non-digestible carbohydrate in the formula, we will study 2 concentrations of added oligofructose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental (EF) 1
For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1
Other: S-26 Gold EF1
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend

Active Comparator: Standard Formula
For 8 weeks, infants will consume ad libitum per day. S-26 Gold
Other: S-26 Gold
(13.4 g/L protein) with 100% Fat Blend A

Experimental: Experimental 2 (EF2) S-26 Gold
For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF2
Other: S-26 Gold EF2
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose

Human milk (HM)
For 8 weeks, infants will consume ad libitum per day. Human Milk
Other: Human Milk
Human Milk

Experimental: Experimental formula (EF) 3
For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF3
Other: S-26 Gold EF3
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose




Primary Outcome Measures :
  1. Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas [ Time Frame: 8 weeks ]
    stool composition: stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents


Secondary Outcome Measures :
  1. Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas [ Time Frame: 8 weeks ]
    Determinations of fecal flora as well as fecal pH, sIgA concentrations and SCFA concentrations in a subset of subjects.


Other Outcome Measures:
  1. Safety evaluation [ Time Frame: 10 weeks ]
    evaluation of adverse events

  2. Growth evaluation [ Time Frame: 8 weeks ]
    Anthropometric measurements



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy, term (no less than 37 weeks, 0 days and no greater than 42 weeks, 0 days) singleton infants, between 7 days and 14 day post natal age
  2. Weight for age ≥5th percentile according to Filipino growth tables/charts.
  3. HM infants were exclusively consuming and tolerating HM
  4. Mother must have made the decision to continue to exclusively breastfeed.
  5. Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula
  6. Parent/guardian must have previously made the decision to continue to exclusively formula feed

Exclusion Criteria:

  1. Infants who are receiving any amount of supplemental HM with infant formula feeding or visa versa
  2. Infants who are receiving any infant formula containing pro- or prebiotics
  3. Family history of siblings with documented cow's milk protein intolerance/allergy
  4. Conditions requiring infant feedings other than those specified in the protocol
  5. Major congenital malformations (e.g. cleft palate, hemangiomas, extremity malformation)
  6. Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus, cytomegalovirus)
  7. Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases
  8. Infants who have received any experimental treatment, participated in any other clinical trial, or received any other investigational intervention unrelated to this trial, prior to enrollment
  9. Infants of any ancillary personnel connected with the study or the infants of first and second-degree relatives (parents, brothers, sisters, children, or grandchildren) of ancillary personnel
  10. Presently receiving or have received any medication(s) which are known or suspected to affect fat digestion, absorption and/or metabolism (e.g., pancreatic enzymes), any vitamin and/or mineral supplements which contain calcium, all antibiotics and antifungal medications (except topical), suppositories, bismuth-containing medications, herbal supplements, or medications which may neutralize or suppress gastric acid secretion
  11. HM-fed infants whose mothers are presently receiving or have received any antibiotics or antifungal medications (except topical), post partum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861600


Locations
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Philippines
Asian Hospital and Medical Center
Metro Manila, Alabang, Philippines, 1780
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Maria Rosario Zeta Capeding, MD JRF Health Center Complex, Muntinlupa City, Philippines

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01861600     History of Changes
Other Study ID Numbers: 9055A1-3001
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Nestlé:
Stool composition