Stool CompositionPhase 3NCT01861600
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
A Phase 3 study testing S-26 Gold, S-26 Gold EF1 and S-26 Gold EF2 in people with Stool Composition, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Stool Composition
- What is being tested?
- S-26 Gold, S-26 Gold EF1 and S-26 Gold EF2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 sitePhilippines
- Study dates
- Apr 2009to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- Weight for age ≥5th percentile according to Filipino growth tables/charts.
- HM infants were exclusively consuming and tolerating HM
- Mother must have made the decision to continue to exclusively breastfeed.
- Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula
- Parent/guardian must have previously made the decision to continue to exclusively formula feed
Who cannot join
- Infants who are receiving any amount of supplemental HM with infant formula feeding or visa versa
- Infants who are receiving any infant formula containing pro- or prebiotics
- Family history of siblings with documented cow's milk protein intolerance/allergy
- Conditions requiring infant feedings other than those specified in the protocol
- Major congenital malformations (e.g. cleft palate, hemangiomas, extremity malformation)
- Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus, cytomegalovirus)
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- Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases
- 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
- 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
- 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
- HM-fed infants whose mothers are presently receiving or have received any antibiotics or antifungal medications (except topical), post partum
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Asian Hospital and Medical Center
Metro Manila, Alabang, 1780
About this study
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.
Read the 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.
- Conditions
- Stool Composition
- Being tested
- S-26 Gold, S-26 Gold EF1, S-26 Gold EF2, S-26 Gold EF3, Human Milk
- Keywords
- Stool composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-26 GoldOther
(13.4 g/L protein) with 100% Fat Blend A
S-26 Gold EF1Other
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend
S-26 Gold EF2Other
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose
S-26 Gold EF3Other
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose
Human MilkOther
Human Milk
| Study group | Role | What they receive |
|---|---|---|
| Experimental (EF) 1 | Experimental | For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1 Receives: Other: S-26 Gold EF1 |
| Standard Formula | Active comparator | For 8 weeks, infants will consume ad libitum per day. S-26 Gold Receives: Other: S-26 Gold |
| Experimental 2 (EF2) S-26 Gold | Experimental | For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF2 Receives: Other: S-26 Gold EF2 |
| Human milk (HM) | Other | For 8 weeks, infants will consume ad libitum per day. Human Milk Receives: Other: Human Milk |
| Experimental formula (EF) 3 | Experimental | For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF3 Receives: Other: S-26 Gold EF3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas
stool composition: stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents
Measured: 8 weeks
Secondary outcomes (1)
Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Determinations of fecal flora as well as fecal pH, sIgA concentrations and SCFA concentrations in a subset of subjects.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stool CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Rosario Zeta Capeding, MD, Principal investigator, JRF Health Center Complex, Muntinlupa City, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861600
- Sponsor's protocol ID
- 9055A1-3001
- Status last verified
- May 2013
- First submitted
- 17 Apr 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443.
PubMed 24840511
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
- ClinicalTrials.gov ID
- NCT01861600
- Acronym / sponsor ID
- 9055A1-3001
- Conditions
- Stool Composition
- Keywords
- Stool composition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental (EF) 1 | Experimental | Other: S-26 Gold EF1For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1 |
| Standard Formula | Active comparator | Other: S-26 GoldFor 8 weeks, infants will consume ad libitum per day. S-26 Gold |
| Experimental 2 (EF2) S-26 Gold | Experimental | Other: S-26 Gold EF2For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF2 |
| Human milk (HM) | Other | Other: Human MilkFor 8 weeks, infants will consume ad libitum per day. Human Milk |
| Experimental formula (EF) 3 | Experimental | Other: S-26 Gold EF3For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF3 |
Who may qualify
- Ages
- 7 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
- Weight for age ≥5th percentile according to Filipino growth tables/charts.
- HM infants were exclusively consuming and tolerating HM
- Mother must have made the decision to continue to exclusively breastfeed.
- Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula
Key exclusion criteria (11 listed)
- Infants who are receiving any amount of supplemental HM with infant formula feeding or visa versa
- Infants who are receiving any infant formula containing pro- or prebiotics
- Family history of siblings with documented cow's milk protein intolerance/allergy
- Conditions requiring infant feedings other than those specified in the protocol
- Major congenital malformations (e.g. cleft palate, hemangiomas, extremity malformation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-26 Gold(13.4 g/L protein) with 100% Fat Blend A | Other | Standard Formula |
| S-26 Gold EF1(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend | Other | Experimental (EF) 1 |
| 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 | Other | Experimental 2 (EF2) S-26 Gold |
| 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 | Other | Experimental formula (EF) 3 |
| Human MilkHuman Milk | Other | Human milk (HM) |
Primary outcome
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
1 secondary outcome
Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
- Derived from this study: PubMed 24840511Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Rosario Zeta Capeding, MD principal investigator
JRF Health Center Complex, Muntinlupa City, Philippines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-26 Gold, S-26 Gold EF1 and S-26 Gold EF2 in people with Stool Composition, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01861600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2013.